Method - Efficient and effective conduct of clinical trials
Lead Research Organisation:
University College London
Department Name: UNLISTED
Abstract
Clinical trials help doctors and patients to make better healthcare decisions. The way that a trial is done and the data collected and checked effects the cost of the trial and also directly effects the confidence we can have in its results. Unfortunately, many of the methods that we use to run trials are not based on high quality evidence. We aim to find better and evidenced based ways of running trials more effectively. Trials can also be very expensive, so we are looking at ways we can make them more cost-effective. For example, we want to understand where and how a patients routine medical records can be used to get quicker and cheaper access to data for trials and where this is not possible.
Academic organisations often investigate new treatments in diseases which are not a priority for the company that has developed that new treatment. We therefore need better ways in which the results of trials being done by academic organisations can be used by regulatory authorities to improve the speed at which these new treatments can be approved and licensed for use in patients with these diseases.
Academic organisations often investigate new treatments in diseases which are not a priority for the company that has developed that new treatment. We therefore need better ways in which the results of trials being done by academic organisations can be used by regulatory authorities to improve the speed at which these new treatments can be approved and licensed for use in patients with these diseases.
Technical Summary
Efficiently and effectively conducted trials produce reliable results in a timely manner. Much current practice for the conduct of trials it is not based on high-quality or sometimes any evidence. This programme focuses on important evidence gaps that we are strategically well-placed to address. During this QQ the Programme has undergone considerable change with new leadership providing oversight and resetting the agenda. Our research includes the following:
• Timely and reliable access to electronic health records has the potential to transform the conduct of many national clinical trials, making them considerably more cost-effective. Our work will involve developing primary evidence on data utility, and collation of experiences and consensus to drive guideline development for the use of electronic health records in trials. The research goals need to be achieved in partnership; we have a strategic partnership with NHS Digital, are an integral part of Heath Data Research UK and are leading the NIHR-MRC Trials Methodology Research Partnership Health Informatics Working Group.
• Clearer communication of trial results will increase impact, improve research transparency, and reduce waste. We are studying how to better provide findings and results to participants and clinicians.
• Novel trial designs are more likely be taken up by others when there are accessible case studies demonstrating successful implementation and documented solutions to challenges. We aim to support successful implementation, particularly adaptive trials testing more than one primary research hypothesis.
• High-quality monitoring of trial data are essential for patient safety and trial integrity. This is a key issue in trial delivery but has been under-researched. We aim to develop a monitoring toolkit to provide resources and a more structured approach to monitoring. We have established a national UKCRN Task and Finish Group in this area.
• Academic interventional phase III clinical trials always aim to impact clinical practice and increasingly impact needs to be achieved through review by regulators and payers. The pace of product development and potential number of potential indications which new therapies might be effective requires that industry and academia build partnerships and to find ways to make academically sponsored and run trials “acceptable” to regulators and payers – a form of regulatory “future-proofing”’ for trials. These regulatory “future-proofed” approaches must be less resource intensive than is standard for industry but must retain confidence of a reliable route to license extension.
• Timely and reliable access to electronic health records has the potential to transform the conduct of many national clinical trials, making them considerably more cost-effective. Our work will involve developing primary evidence on data utility, and collation of experiences and consensus to drive guideline development for the use of electronic health records in trials. The research goals need to be achieved in partnership; we have a strategic partnership with NHS Digital, are an integral part of Heath Data Research UK and are leading the NIHR-MRC Trials Methodology Research Partnership Health Informatics Working Group.
• Clearer communication of trial results will increase impact, improve research transparency, and reduce waste. We are studying how to better provide findings and results to participants and clinicians.
• Novel trial designs are more likely be taken up by others when there are accessible case studies demonstrating successful implementation and documented solutions to challenges. We aim to support successful implementation, particularly adaptive trials testing more than one primary research hypothesis.
• High-quality monitoring of trial data are essential for patient safety and trial integrity. This is a key issue in trial delivery but has been under-researched. We aim to develop a monitoring toolkit to provide resources and a more structured approach to monitoring. We have established a national UKCRN Task and Finish Group in this area.
• Academic interventional phase III clinical trials always aim to impact clinical practice and increasingly impact needs to be achieved through review by regulators and payers. The pace of product development and potential number of potential indications which new therapies might be effective requires that industry and academia build partnerships and to find ways to make academically sponsored and run trials “acceptable” to regulators and payers – a form of regulatory “future-proofing”’ for trials. These regulatory “future-proofed” approaches must be less resource intensive than is standard for industry but must retain confidence of a reliable route to license extension.
Organisations
- University College London (Lead Research Organisation)
- KIDNEY RESEARCH UK (Collaboration)
- University of Basel (Collaboration)
- National University of Ireland, Galway (Collaboration)
- Translational Health Science And Technology Institute (Collaboration)
- Medicines and Healthcare Regulatory Agency (Collaboration)
- Eisai Ltd (Collaboration)
- Health Data Research UK (Collaboration)
- Irish Health Research Board (Collaboration)
- UK Clinical Research Collaboration (Collaboration)
- QUEEN MARY UNIVERSITY OF LONDON (Collaboration)
- NHS DIGITAL (Collaboration)
- Amgen Inc (Collaboration)
- Janssen Pharmaceutica NV (Collaboration)
- Cardiff University (Collaboration)
- University College Cork (Collaboration)
- UNIVERSITY OF BIRMINGHAM (Collaboration)
- Roche Pharmaceuticals (Collaboration)
- UNIVERSITY OF LEEDS (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- UNIVERSITY OF LIVERPOOL (Collaboration)
- Medical Research Council (MRC) (Collaboration)
- University of Bristol (Collaboration)
- University College London (Collaboration)
- UNIVERSITY OF NOTTINGHAM (Collaboration)
- UKCRC Registered trials CTU network (Collaboration)
- QUEEN'S UNIVERSITY BELFAST (Collaboration)
- University of Dundee (Collaboration)
- IMPERIAL COLLEGE LONDON (Collaboration)
- UNIVERSITY OF OXFORD (Collaboration)
- AstraZeneca (United Kingdom) (Collaboration)
- Bayer (Collaboration)
- PSI (Collaboration)
- Alan Turing Institute (Collaboration)
- Institute of Cancer Research UK (Collaboration)
- London School of Hygiene and Tropical Medicine (LSHTM) (Collaboration)
- NHS HEALTH RESEARCH AUTHORITY (Collaboration)
- UNIVERSITY OF EDINBURGH (Collaboration)
- Christian Medical College, Vellore (Collaboration)
- KING'S COLLEGE LONDON (Collaboration)
People |
ORCID iD |
Publications
McCarthy M
(2023)
Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.
in HRB open research
McCarthy M
(2021)
A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE).
in HRB open research
McErlean M
(2023)
The reporting standards of randomised controlled trials in leading medical journals between 2019 and 2020: a systematic review.
in Irish journal of medical science
Meade A
(2021)
RAMPART: A model for a regulatory-ready academic-led phase III trial in the adjuvant renal cell carcinoma setting.
in Contemporary clinical trials
Mintz H
(2023)
Making administrative healthcare systems clinical data the future of clinical trials: lessons from BladderPath
in BMJ Oncology
Mirza A
(2021)
Why are feasibility studies accessing routinely collected health data? A systematic review
in F1000Research
Mitchell EJ
(2023)
e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence.
in Trials
Murray ML
(2022)
Data provenance and integrity of health-care systems data for clinical trials.
in The Lancet. Digital health
Related Projects
| Project Reference | Relationship | Related To | Start | End | Award Value |
|---|---|---|---|---|---|
| MC_UU_00004/01 | 01/04/2021 | 31/03/2026 | £5,186,000 | ||
| MC_UU_00004/02 | Transfer | MC_UU_00004/01 | 01/04/2021 | 31/03/2026 | £4,446,000 |
| MC_UU_00004/03 | Transfer | MC_UU_00004/02 | 01/04/2021 | 31/03/2026 | £4,999,000 |
| MC_UU_00004/04 | Transfer | MC_UU_00004/03 | 01/04/2021 | 31/03/2026 | £5,315,000 |
| MC_UU_00004/05 | Transfer | MC_UU_00004/04 | 01/04/2021 | 31/03/2026 | £3,107,000 |
| MC_UU_00004/06 | Transfer | MC_UU_00004/05 | 01/04/2021 | 31/03/2026 | £2,889,000 |
| MC_UU_00004/07 | Transfer | MC_UU_00004/06 | 01/04/2021 | 31/03/2026 | £2,369,000 |
| MC_UU_00004/08 | Transfer | MC_UU_00004/07 | 01/04/2021 | 31/03/2026 | £2,270,000 |
| MC_UU_00004/09 | Transfer | MC_UU_00004/08 | 01/04/2021 | 31/03/2026 | £2,160,000 |
| Description | Contribution to, and recommendations captured in, Goldacre Report (2022) |
| Geographic Reach | National |
| Policy Influence Type | Contribution to a national consultation/review |
| URL | https://www.gov.uk/government/publications/better-broader-safer-using-health-data-for-research-and-a... |
| Description | Data flows at NHS England: data integrity |
| Geographic Reach | National |
| Policy Influence Type | Contribution to new or improved professional practice |
| Impact | Through discussion, secondment and evidence generation, influenced NHS England (was NHS Digital) to change documentation processes to document flow of data from hospital electronic health records systems into NHSE datasets to confirm they are a reliable transcribed copy of the source data (which helps clinical trials). Process near complete for some datasets, ongoing for others. |
| Description | ICTMC 2022 Chair |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Participation in a guidance/advisory committee |
| URL | https://ictmc.org/ |
| Description | Influence UK Health Research Authority processes for reviewing platform clinical trials |
| Geographic Reach | National |
| Policy Influence Type | Contribution to new or improved professional practice |
| Impact | Allows better and more proportionate review of platform protocols by ethics committees. These can be complicated to explain and previous processes did not well capture the necessary information, particularly for amendments that involved adding new research comparisons. |
| Description | Influence on MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions |
| Geographic Reach | National |
| Policy Influence Type | Citation in other policy documents |
| Impact | MHRA update guidlines to say: "5. Examples of scenarios, endpoints and designs Noting the points above, an example of a suitable scenario for a RWD based trial and an appropriate design would be: [Truncated] An objective endpoint routinely and consistently collected in the EHR database(s) for the patient population considered of interest. For example, all-cause mortality and inpatient hospitalisations are known to be well recorded in the UK general population. Disease specific outcomes may require assessment within the proposed study population (e.g., HbA1c is known to be well recorded in primary care for the diabetic population, but less so for the general population)" [Truncated] Mention of HES APC and Death datasets is taken directly from our work and discussions with MHRA in Jul-2021, Oct-2021 and our discussions around these points, including their commenting on our report. They have put out this information without attribution to our work (we have asked for an update) and before our report was made public on https://zenodo.org/record/6047155 |
| URL | https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-s... |
| Description | Monitoring of Clinical trials - a handbook |
| Geographic Reach | National |
| Policy Influence Type | Influenced training of practitioners or researchers |
| Impact | There was no handbook about the practicalities of clinical trial monitoring. I co-devised this and wrote one section. We distributed it free so that all can access it. |
| URL | https://ukcrc-ctu.org.uk/guidance-for-ctus/ |
| Description | Update HRA review of platform protocols (REC Member Information Exchange 32 - June 2021) |
| Geographic Reach | National |
| Policy Influence Type | Implementation circular/rapid advice/letter to e.g. Ministry of Health |
| Impact | Health Research Authority newsletter sets out new processes to 852 members (including lay members) of UK Research Ethics Committeees (RECs). Text below: ================================ REC Member Information Exchange 32 - June 2021 == Contents Page == [removed] 5. Complex Innovative Design Trials [removed] == 5. Complex Innovative Design trials == A "Complex Innovative Design" trial is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. These trials are also sometimes referred to as platform, adaptive or umbrella trials. Trials in this Complex Innovative Design family can offer flexible features such as stopping recruitment early to treatments which are not being active enough, or adding new research questions (comparisons) to be evaluated during the course of a trial. These trials, like many clinical trials, may be able to declare early that one or more treatments are superior. These issues need to be thought about carefully by the trial team before the trial starts. Many of you will have attended one of five workshops ran by Matt Sydes and Louise Brown from the MRC Clinical Trials Unit at UCL as part of the programme for the Regional REC member training days held across 2019 and 2020. The sessions led by Matt and Louise involved presentations on the benefits and challenges of adding comparisons into ongoing protocols and guided group discussions on issues specific to the ethics review. Since the regional training days, Matt and Louise have collated and reviewed the feedback from REC members who attended the workshops and have continued to work with the HRA and provide valuable input in terms of the ethics review process for Complex Innovative Design trials. During the last year, a number of COVID-19 trials have used complex, innovative designs and therefore, more RECs will have now started reviewing such trials. It is likely that this type of trial design will continue to be used more frequently due to the benefits of utilising an adaptive approach. We would like to take this opportunity to provide members with an update on the actions which have been taken forward since the regional training days: REC Members agreed that it needed to be clearer at the outset whether a study was a Complex Innovative Design trial. There will be a question in the new version of IRAS to flag this type of trial - this is already live for CTIMPs using the new application form for Combined Ways of Working. Feedback from members was that they were sometimes concerned about reviewing substantial amendments to Complex Innovative Design trials due to the scale of the changes involved in the amendment (e.g. introducing a new arm). A revised version of the Standard Operating Procedures for Research Ethics Committees was published in March and included the following paragraph to remind members that a new application should not be requested in these instances but that the Sub-Committee may involve more members in the review of the amendment if they considered that wider consultation would be helpful: 'By virtue of their design, studies which have been set up as Complex Innovative Design trials (sometimes referred to as adaptive, platform or umbrella trials) may add different interventions or may recruit new categories of participants as the study progresses. For Complex Innovative Trials, it is acceptable for these changes to be submitted as a substantial amendment rather than as a new application. However, for trials to come under the heading of a Complex Innovative Trial, the protocol must have been approved by the REC on this basis when the study was originally reviewed and the methodology included in the protocol should have been clear about the scope for future phases, treatment arms or other adaptive features. Where the changes included in the amendment are particularly significant, the amendment may be reviewed by a Sub-Committee involving a larger number of members or by reviewing the amendment at a full REC meeting' In addition to the above, REC members should also request the member of staff supporting their REC to contact the MHRA Medical Assessor if there is an aspect related to the safety or clinical evidence which they are unsure about when reviewing the amendment REC Members who attended the workshops requested further training in how to ethically review Complex Innovative Design trials. There is now a series of podcasts which members can access, including one specifically directed at REC members. We are also hoping to include a Complex Innovative Design trial in one of our focussed discussion workshops for members to debate. REC Members stipulated that the clarity of the description of the amendment was important and the changes needed to be presented as succinctly as possible. The following suggestions were agreed and we will be looking at how best to encourage applicants to present information in this way as part of their substantial amendment: • An updated trial schema indicating how the trial has changed from the previous version. • A clear covering letter which should include a statement of whether a new comparison (with a new research arm) has been added. • A short form highlighting the documents impacted by the proposed amendment) and clarity on who has already scientifically peer-reviewed these changes. We would like to take this opportunity to express our thanks to Matt and Louise for the work which they have undertaken with the HRA and with REC members in delivering the training and helping us take these initiatives forward. |
| Description | member of consensus committee for SPIRIT-CONSORT |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Contribution to a national consultation/review |
| Description | 22/104 HTA Application Acceleration Award - platform studies in areas considered strategic priorities |
| Amount | £197,936 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2023 |
| End | 02/2024 |
| Description | HDR UK Directors Discretionary Fund Award |
| Amount | £120,000 (GBP) |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 06/2022 |
| End | 03/2023 |
| Description | HDR UK Directors Discretionary Fund Award |
| Amount | £50,449 (GBP) |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 06/2022 |
| End | 03/2023 |
| Description | HDR UK Directors Discretionary Fund Award |
| Amount | £80,000 (GBP) |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 06/2022 |
| End | 03/2023 |
| Description | Health Data Research UK (QQ2: funded by consortium of ~10 funders, coordinated by UKRI) |
| Amount | £72,000,000 (GBP) |
| Organisation | United Kingdom Research and Innovation |
| Sector | Public |
| Country | United Kingdom |
| Start | 04/2023 |
| End | 03/2028 |
| Description | QualShare - Irish HBR Trials Methodology call |
| Amount | € 10,000 (EUR) |
| Funding ID | QualShare |
| Organisation | Trials Methodology Research Network |
| Sector | Private |
| Country | Ireland |
| Start | 04/2021 |
| End | 04/2022 |
| Description | SPIRIT-EHR |
| Amount | € 10,000 (EUR) |
| Organisation | Trials Methodology Research Network |
| Sector | Private |
| Country | Ireland |
| Start | 04/2021 |
| End | 04/2022 |
| Description | Sustainable clinical trials -- NIHR CTU efficiency call |
| Amount | £76,284 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2021 |
| End | 09/2022 |
| Description | TMRP Doctoral Training Programme |
| Amount | £2,518,806 (GBP) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2021 |
| End | 09/2026 |
| Title | Considerations for a Participant Data Sharing SOP |
| Description | Report: published guideline with UKCRC |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | Not known |
| URL | https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf |
| Title | Considerations for a Participant Data Sharing SOP |
| Description | Report: published guideline with UKCRC |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | Not known |
| URL | https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf |
| Title | Data provenance of four NHS Digital (now NHS England) datasets |
| Description | Data provenance information of four frequently used datasets held by NHS England (formerly NHS Digital) can be accessed through the Central Metastore (the metadata catalogue). The datasets are: Admitted Patient Care, Outpatients and Critical Care of Hospital Episode Statistics, and the Civil Registration of Deaths. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2022 |
| Provided To Others? | Yes |
| Impact | Users of the datasets can request access to the Central Metastore at NHSE to obtain detailed information and data flow diagrams of the four datasets, showing how the data are processed within NHSE. |
| Title | Monitoring of Clinical Trials - online training modules |
| Description | This is a new online training resource for staff who undertake trial monitoring as part of their work. The four modules, (listed below) were developed by the UKCRC Monitoring Task and Finish Group with the assistance of a number of additional monitoring representatives from across the Network. 1 - Introduction to the Principles of Monitoring https://vimeo.com/686768464 2 - On-Site Monitoring https://vimeo.com/685860809 3 - Remote Monitoring https://vimeo.com/688822203 4 - Central Monitoring https://vimeo.com/680525693 The NIHR have also added the link to this online training from their toolkit https://www.ct-toolkit.ac.uk/ |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2022 |
| Provided To Others? | Yes |
| Impact | The modules were run live to 160 people interested in clinical trial monitoring on 30Nov2021 with good feedback. This release allow people to watch any module when they want to. |
| URL | https://ukcrc-ctu.org.uk/guidance-for-ctus/ |
| Title | New data sharing tracker system (pilot starts 2023) |
| Description | New tracker system to allow CTU to better track incoming data sharing / data release requests and which pushes reminders for outputs to successful applicants which should allow better tracking of eventual outputs for include in researchfish. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2023 |
| Provided To Others? | No |
| Impact | Going into pilot early in 2023 so no impacts yet. Could have broader use across the other CTUs at UCL, too, in due course and potential for other places where data sharing requests are received. |
| Title | Operating manual to import data provenance information into metadata tools. |
| Description | Describes steps for importing data lineage/provenance information into metadata and data mapping tools such as Collibra and Mauro. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2023 |
| Provided To Others? | Yes |
| Impact | Provides guidance to the wider trials and data science communities on how data provenance information can be captured in metadata tools. |
| Title | SWAT 167: trial monitoring |
| Description | Template published for SWAT 167: Risk-based trial monitoring: Site performance metrics across time. Allows other groups to run same assessment in consistent way. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2022 |
| Provided To Others? | Yes |
| Impact | Others planning to use but none yet |
| URL | https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoup... |
| Title | Systematic review of the prevalence and assessment of language-related eligibility criteria in patient recruitment to type 2 diabetes and depression trials. |
| Description | Published research protocol for ongoing work |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | Not known |
| Title | Use of NHS Digital datasets as trial data in the UK: a position paper |
| Description | Detailed report of data integrity work; commentary version to be submitted separately |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2022 |
| Provided To Others? | Yes |
| Impact | Not known |
| URL | https://zenodo.org/record/6047155#.YiJSY_nP2Uk |
| Title | Datasets for the Alan Turing's Data Study Group on potential use of Machine Learning in Trial Monitoring |
| Description | As part of our collaboration with the Alan Turing Institute, we participated as project owners in the Data Study Group (DSG) held in December 2021. The project looked into potential use of Machine Learning algorithms in trial monitoring. For the DSG we supplied three sets of datasets: (1) Case Report Forms (CRF) data from an oncology clinical trial, (2) Monitoring trigger and finding reports for the same trial, and (3) trigger and findings data from the TEMPER study, which is also originated from the same oncology trial. These datasets were shared exclusively to the DSG participants, by uploading them to the Alan Turing's Data Safe Haven. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2021 |
| Provided To Others? | No |
| Impact | The datasets were used to try a range of Machine Learning algorithms, which gave an insight of what approaches have greater potential of being used in trial monitoring, as well as informing the next steps in this ongoing research project. One of the next steps is the generation of further datasets (subsets, change in format). |
| Title | Feasibility trials using electronic health data from registries |
| Description | This is data on the 15 feasibility trials found in a systematic review of randomised controlled trials (RCTs) accessing routinely collected health data (RCHD) in the UK. The systematic review, published in 20201, considered successful applications for RCHD (such as NHS Digital) detailed in publicly accessible release registers. The release registers were searched in January to May 2019 and data was extracted on every RCT receiving data between 2013 and 2018. This dataset comprises information on the 15 feasibility trials who received routine data during this period. A paper detailing the methodology and findings has been published: Mirza A, Yorke-Edwards V, Lensen S et al. Why are feasibility studies accessing routinely collected health data? A systematic review. F1000Research 2021, 10:815 |
| Type Of Material | Database/Collection of data |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | Not known |
| URL | https://doi.org/10.5522/04/14743836 |
| Title | Feasibility trials using electronic health data from registries |
| Description | This is data on the 15 feasibility trials found in a systematic review of randomised controlled trials (RCTs) accessing routinely collected health data (RCHD) in the UK. The systematic review, published in 20201, considered successful applications for RCHD (such as NHS Digital) detailed in publicly accessible release registers. The release registers were searched in January to May 2019 and data was extracted on every RCT receiving data between 2013 and 2018. This dataset comprises information on the 15 feasibility trials who received routine data during this period. We are submitting a paper on these trials to F1000Research and will update with details and a url once this has been assigned. The dataset is provided as a .txt file, with columns separated by | [pipe/ vertical bar]. 1. Lensen S, Macnair A, Love SB, et al. Access to routinely collected health data for clinical trials - review of successful data requests to UK registries. Trials 2020; 21. doi: 10.1186/s13063-020-04329-8 |
| Type Of Material | Database/Collection of data |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | None known |
| URL | https://rdr.ucl.ac.uk/articles/dataset/Feasibility_trials_using_electronic_health_data_from_registri... |
| Title | Reporting of Trial Monitoring in RCT Protocol Papers |
| Description | This is data from a systematic review of the reporting of monitoring in protocol papers of randomised controlled trials (RCTs). The systematic review was conducted in April to June 2020 in seven journals that commonly publish clinical trial protocol papers, and in papers published by the BioMed Central publishing group. Data was extracted on each protocol paper published between 1st January and 31st May 2020. This dataset comprises information on the extent of the reporting of monitoring in each protocol paper.We are submitting a paper on this systematic review for publication and will update with details and a url when available.The dataset is provided as a .csv file, with columns separated by | [pipe/ vertical bar]. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | Not known |
| URL | https://rdr.ucl.ac.uk/articles/dataset/Reporting_of_Trial_Monitoring_in_RCT_Protocol_Papers/14770731 |
| Title | STAMPEDE monitoring data for Alan Turing Institute Data Study Group Challenge |
| Description | Dataset about and around data from STAMPEDE trial, constructured so participants of Alan Turing Institute Data Study Group Challenge could investigate |
| Type Of Material | Database/Collection of data |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | None yet. Not publicly available. |
| Description | Alan Turing Institute and AI |
| Organisation | Alan Turing Institute |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | This collaboration is in two parts: clinical trial monitoring, and treatment effect heterogeneity. 1. We have described the problems in monitoring of clinical trial data. We are supplying data sets, information about monitoring and on-hand expertise to allow an exploration of the use of AI. 2. For the treatment effect heterogeneity project, we are supplying our expertise on treatment effect estimation in clinical trials, new work on performance measures for treatment effect heterogeneity, and data from a trial in treatmnet of severe anaemia in African children |
| Collaborator Contribution | Scientists of the Alan Turing Institute are using AI including ML on our clinical trial data and on simulated data to find out what methods can be used in the two settings above. A data study group has been run on the monitoring project (entered separately in Research Fish). |
| Impact | A data study group was run in November and December 2021, allowing a group of volunteers to work intensively on the monitoring problem. |
| Start Year | 2019 |
| Description | Alan Turing Institute and AI |
| Organisation | Health Data Research UK |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | This collaboration is in two parts: clinical trial monitoring, and treatment effect heterogeneity. 1. We have described the problems in monitoring of clinical trial data. We are supplying data sets, information about monitoring and on-hand expertise to allow an exploration of the use of AI. 2. For the treatment effect heterogeneity project, we are supplying our expertise on treatment effect estimation in clinical trials, new work on performance measures for treatment effect heterogeneity, and data from a trial in treatmnet of severe anaemia in African children |
| Collaborator Contribution | Scientists of the Alan Turing Institute are using AI including ML on our clinical trial data and on simulated data to find out what methods can be used in the two settings above. A data study group has been run on the monitoring project (entered separately in Research Fish). |
| Impact | A data study group was run in November and December 2021, allowing a group of volunteers to work intensively on the monitoring problem. |
| Start Year | 2019 |
| Description | Alan Turing Institute and AI - Data Study Group |
| Organisation | Alan Turing Institute |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We have described the problems in monitoring of clinical trial data. Phase III clinical trials are typically multicentre (50-200 sites) and recruit several hundred patients (300-10000). ICH GCP E6(R2) say "Clinical trialists monitor trial data in order to protect the rights and well-being of participants, to ensure that the trial data are accurate, complete, and verifiable, and to confirm that the trial is being run in compliance with the currently approved protocol, with the principles of good clinical practice (GCP), and with the relevant regulatory requirements". This monitoring can take 25% of the CTU trial budget. With risk based monitoring, we consider the risks to the patients and the trial and devise the monitoring to reduce or mitigate these risks. It may be more efficient to use AI (or ML) to look at the full dataset and find what data areas and sites we need to target, rather than use our ideas of risk and solution. We are supplying data sets, information about monitoring and on-hand expertise to allow an exploration of the use of AI. |
| Collaborator Contribution | ATI will provide funding for project work for the week. Scientists of the Alan Turing Institute will use AI including ML on our clinical trial data to find out what data areas and sites we need to approach to improve the clinical trial data. We will have monitoring experts from the clinical trials unit on hand to give any explanations required and check the process is on track. |
| Impact | The data study group was run in November and December 2021, allowing a group of volunteers to work intensively on the monitoring problem. A report is currently being written. |
| Start Year | 2021 |
| Description | Alan Turing Institute and AI - Data Study Group |
| Organisation | Health Data Research UK |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | We have described the problems in monitoring of clinical trial data. Phase III clinical trials are typically multicentre (50-200 sites) and recruit several hundred patients (300-10000). ICH GCP E6(R2) say "Clinical trialists monitor trial data in order to protect the rights and well-being of participants, to ensure that the trial data are accurate, complete, and verifiable, and to confirm that the trial is being run in compliance with the currently approved protocol, with the principles of good clinical practice (GCP), and with the relevant regulatory requirements". This monitoring can take 25% of the CTU trial budget. With risk based monitoring, we consider the risks to the patients and the trial and devise the monitoring to reduce or mitigate these risks. It may be more efficient to use AI (or ML) to look at the full dataset and find what data areas and sites we need to target, rather than use our ideas of risk and solution. We are supplying data sets, information about monitoring and on-hand expertise to allow an exploration of the use of AI. |
| Collaborator Contribution | ATI will provide funding for project work for the week. Scientists of the Alan Turing Institute will use AI including ML on our clinical trial data to find out what data areas and sites we need to approach to improve the clinical trial data. We will have monitoring experts from the clinical trials unit on hand to give any explanations required and check the process is on track. |
| Impact | The data study group was run in November and December 2021, allowing a group of volunteers to work intensively on the monitoring problem. A report is currently being written. |
| Start Year | 2021 |
| Description | AstraZeneca start-up funding toward RAMPART international renal cancer adjuvant trial |
| Organisation | AstraZeneca |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | An international consortium of key investigators in this field and a novel trial design |
| Collaborator Contribution | Provision of start-up funds and drug information in support of the planned trial (which will itself have further funding) |
| Impact | Development of trial underway and in discussion with regulatory authorities |
| Start Year | 2016 |
| Description | Data Utility Comparisons in STAMPEDE (DUCkS) |
| Organisation | Institute of Cancer Research UK |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | MRC CTU leading project |
| Collaborator Contribution | NHS Digital supplying data ICR providing clinical guidance |
| Impact | Pending |
| Start Year | 2022 |
| Description | Data Utility Comparisons in STAMPEDE (DUCkS) |
| Organisation | NHS Digital |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | MRC CTU leading project |
| Collaborator Contribution | NHS Digital supplying data ICR providing clinical guidance |
| Impact | Pending |
| Start Year | 2022 |
| Description | Data sharing for qualitative data for clinical trials |
| Organisation | National University of Ireland, Galway |
| Country | Ireland |
| Sector | Academic/University |
| PI Contribution | 10,000 Euro grant to NUI Galway to research in the topic from Irish HRB Trials Methodology Research Network. To explore issues in data sharing from clinical trials where qualitative data have been collected. |
| Collaborator Contribution | Led from NUI Galway |
| Impact | None yet |
| Start Year | 2020 |
| Description | Edition of IDMC course with HRB TMRN |
| Organisation | Irish Health Research Board |
| Country | Ireland |
| Sector | Charity/Non Profit |
| PI Contribution | Led edition of UCL's short course on Data Monitoring Committees |
| Collaborator Contribution | Arranged attendees, contributed some faculty |
| Impact | Further potential IDMC members and people that might report to them trained. Discussions with HRB re policy improvement. |
| Start Year | 2022 |
| Description | HDR London (Health Data Research, London) |
| Organisation | Imperial College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Lead the London bid for the trials component, one of five active sites in London |
| Collaborator Contribution | Active in HDR UK team for London sites |
| Impact | None yet |
| Start Year | 2018 |
| Description | HDR London (Health Data Research, London) |
| Organisation | King's College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Lead the London bid for the trials component, one of five active sites in London |
| Collaborator Contribution | Active in HDR UK team for London sites |
| Impact | None yet |
| Start Year | 2018 |
| Description | HDR London (Health Data Research, London) |
| Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Lead the London bid for the trials component, one of five active sites in London |
| Collaborator Contribution | Active in HDR UK team for London sites |
| Impact | None yet |
| Start Year | 2018 |
| Description | HDR London (Health Data Research, London) |
| Organisation | Queen Mary University of London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Lead the London bid for the trials component, one of five active sites in London |
| Collaborator Contribution | Active in HDR UK team for London sites |
| Impact | None yet |
| Start Year | 2018 |
| Description | HDR UK and TMRP |
| Organisation | Health Data Research UK |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Representation on TMRP Exec, Health Informatics (for Trials) Working Grup and together for projects |
| Collaborator Contribution | Coordination and small grant points HTMR Network now known as Trials Methodology Research Partnership |
| Impact | First national meeting on trials (Jan-2021) |
| Start Year | 2020 |
| Description | HDR UK and TMRP |
| Organisation | Medical Research Council (MRC) |
| Department | Network of Hubs for Trials Methodology Research (HTMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Representation on TMRP Exec, Health Informatics (for Trials) Working Grup and together for projects |
| Collaborator Contribution | Coordination and small grant points HTMR Network now known as Trials Methodology Research Partnership |
| Impact | First national meeting on trials (Jan-2021) |
| Start Year | 2020 |
| Description | Health Data Research UK (HDR UK) QQ2 bid > Infrastructure > Trials |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | M Sydes invited to co-lead, with Marion Mafham of Oxford, the QQ2 bid for the Trials element of HDR UK. |
| Collaborator Contribution | Trials element to be co-led from UCL, Oxford, Cardiff and Dundee. Multiple universities around the UK partners in HDR UK overall. |
| Impact | Grant awarded and starts Apr-2023. Collaboration is across methodology, statistics, clinical and operations. |
| Start Year | 2021 |
| Description | Health Data Research UK (HDR UK) QQ2 bid > Infrastructure > Trials |
| Organisation | Health Data Research UK |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | M Sydes invited to co-lead, with Marion Mafham of Oxford, the QQ2 bid for the Trials element of HDR UK. |
| Collaborator Contribution | Trials element to be co-led from UCL, Oxford, Cardiff and Dundee. Multiple universities around the UK partners in HDR UK overall. |
| Impact | Grant awarded and starts Apr-2023. Collaboration is across methodology, statistics, clinical and operations. |
| Start Year | 2021 |
| Description | Health Data Research UK (HDR UK) QQ2 bid > Infrastructure > Trials |
| Organisation | University of Dundee |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | M Sydes invited to co-lead, with Marion Mafham of Oxford, the QQ2 bid for the Trials element of HDR UK. |
| Collaborator Contribution | Trials element to be co-led from UCL, Oxford, Cardiff and Dundee. Multiple universities around the UK partners in HDR UK overall. |
| Impact | Grant awarded and starts Apr-2023. Collaboration is across methodology, statistics, clinical and operations. |
| Start Year | 2021 |
| Description | Health Data Research UK (HDR UK) QQ2 bid > Infrastructure > Trials |
| Organisation | University of Oxford |
| Department | Oxford Hub |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | M Sydes invited to co-lead, with Marion Mafham of Oxford, the QQ2 bid for the Trials element of HDR UK. |
| Collaborator Contribution | Trials element to be co-led from UCL, Oxford, Cardiff and Dundee. Multiple universities around the UK partners in HDR UK overall. |
| Impact | Grant awarded and starts Apr-2023. Collaboration is across methodology, statistics, clinical and operations. |
| Start Year | 2021 |
| Description | Healthcare systems data for clinical trials: data integrity |
| Organisation | NHS Digital |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Leadership of project and coordination |
| Collaborator Contribution | Discussion, data, engagement |
| Impact | Report: https://zenodo.org/record/6047155#.YiXW1fnP2Uk Paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9296098/pdf/main.pdf Subsequent funding: DEDICATE project |
| Start Year | 2021 |
| Description | Healthcare systems data for clinical trials: data integrity |
| Organisation | University College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Leadership of project and coordination |
| Collaborator Contribution | Discussion, data, engagement |
| Impact | Report: https://zenodo.org/record/6047155#.YiXW1fnP2Uk Paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9296098/pdf/main.pdf Subsequent funding: DEDICATE project |
| Start Year | 2021 |
| Description | Healthcare systems data for clinical trials: data integrity |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Leadership of project and coordination |
| Collaborator Contribution | Discussion, data, engagement |
| Impact | Report: https://zenodo.org/record/6047155#.YiXW1fnP2Uk Paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9296098/pdf/main.pdf Subsequent funding: DEDICATE project |
| Start Year | 2021 |
| Description | Implementation of platform protocols: exchange visit |
| Organisation | University of Basel |
| Country | Switzerland |
| Sector | Academic/University |
| PI Contribution | Overlapping interests leading to MRC CTU-funded exchange visit with University of Basel staff attending CTU for one week and MRC CTU staff visiting Basel for 2 days in March 2023 |
| Collaborator Contribution | Discussion of current practice and research plans. |
| Impact | Pending |
| Start Year | 2023 |
| Description | Improving review of platfom protocols by Health Research Authority and Research Ethics Committees |
| Organisation | NHS Health Research Authority |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Provided (MSy, LB) 1 hour training-and-discussion session at 5 regional meetings for HRA (Leicester, Leeds, Oxford in 2019 and London and Manchester in 2021) on implementation on platform protocols and challenges in ethics review when clinical trial questions are added to an ongoing protocol. Proposed guidance on reviewing of platform protocols presented to HRA in Mar-2021. |
| Collaborator Contribution | Organisation of meetings and invitation of attendees (REC members) |
| Impact | Draft guidance developed by MRC CTU and presented to HRA on improving review of platform protocols. Too recent for impact. |
| Start Year | 2019 |
| Description | Language for trial consent |
| Organisation | University College London |
| Department | Institute of Education (IOE) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Led by Talia Isaacs at UCL IOE. Grant to Talia for £10K to support improvements in language around recruitment to clinical trials. CTU provide some motivating examples. Also input from University of Aberdeen; University College Cork; HRB Trials Methodology Research Network Ireland; National University Ireland, Galway; Dartmouth College; and University of Leicester |
| Collaborator Contribution | Work starting Mar-2021 |
| Impact | None yet |
| Start Year | 2021 |
| Description | MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group |
| Organisation | NHS Digital |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support. |
| Collaborator Contribution | Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements. |
| Impact | None yet |
| Start Year | 2021 |
| Description | MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support. |
| Collaborator Contribution | Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements. |
| Impact | None yet |
| Start Year | 2021 |
| Description | MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group |
| Organisation | University of Bristol |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support. |
| Collaborator Contribution | Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements. |
| Impact | None yet |
| Start Year | 2021 |
| Description | MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group |
| Organisation | University of Leeds |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support. |
| Collaborator Contribution | Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements. |
| Impact | None yet |
| Start Year | 2021 |
| Description | MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support. |
| Collaborator Contribution | Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements. |
| Impact | None yet |
| Start Year | 2021 |
| Description | MRC - NIHR Trials Methodology Research Partnership's Health Informatics (for Trials) Working Group |
| Organisation | University of Oxford |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Matt Sydes co-chairs first incarnation of Health Informatics (for Trials) Working Group with Amanda Farrin (Leeds). Set up 6 Topic Groups under the Working Group on which UCL is represented. Each Topic Group is seeking driver projects in the area to improve specific aspects of the delivery of trials. The collaborator list above selects only those universities who are chairing a Topic Group or who providing TMRP secretariat support. |
| Collaborator Contribution | Around 25 universities on the Working Group and Topic Group. Developing projects and scope for evidence based improvements. |
| Impact | None yet |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Amgen Inc |
| Country | United States |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | AstraZeneca |
| Department | Astra Zeneca |
| Country | United States |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Bayer |
| Country | Germany |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Cardiff University |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Eisai Ltd |
| Country | Japan |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | GlaxoSmithKline (GSK) |
| Country | Global |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Janssen Pharmaceutica NV |
| Country | Belgium |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | Roche Pharmaceuticals |
| Country | Global |
| Sector | Private |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | Membership of European Forum for Statisticians in the Pharmaceutical Industry (EFSPI) Special Interest Group (SIG) in Data Sharing |
| Organisation | University of Liverpool |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Membership https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group |
| Collaborator Contribution | Active contribution to discussions and plans. Bringing academic perspective. |
| Impact | Discussions. Outputs to vfollow. |
| Start Year | 2021 |
| Description | NHS England (was NHS Digital) collaboration |
| Organisation | NHS Digital |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Strategic and collaborative input |
| Collaborator Contribution | Strategic and collaborative input Input through various committees |
| Impact | (None yet) |
| Start Year | 2020 |
| Description | NIHR Task and Finish group for data sharing |
| Organisation | Queen Mary University of London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Part of group making recommendations on data sharing. Liverpool chaired; UKCRC CTU Network coordinated. |
| Collaborator Contribution | Part of group |
| Impact | Guidance: https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf |
| Start Year | 2015 |
| Description | NIHR Task and Finish group for data sharing |
| Organisation | UKCRC Registered trials CTU network |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Part of group making recommendations on data sharing. Liverpool chaired; UKCRC CTU Network coordinated. |
| Collaborator Contribution | Part of group |
| Impact | Guidance: https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf |
| Start Year | 2015 |
| Description | NIHR Task and Finish group for data sharing |
| Organisation | University of Edinburgh |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Part of group making recommendations on data sharing. Liverpool chaired; UKCRC CTU Network coordinated. |
| Collaborator Contribution | Part of group |
| Impact | Guidance: https://ukcrc-ctu.org.uk/wp-content/uploads/2021/04/data_sharing_sop_guide_v1.1_-1.pdf |
| Start Year | 2015 |
| Description | PERSEVERE |
| Organisation | University of Leeds |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Hosted first meeting of PERSEVERE group to consider issues around premature stopping of participation to clinical trials. CTU joined a number of small, short-term working parties, subsequently. Nationwide input. |
| Collaborator Contribution | Ex-CTU employee now at Leeds proposed the project |
| Impact | (None yet) |
| Start Year | 2019 |
| Description | PSI/EFSPI/ASA-BIOP: CSM/QTL Working group |
| Organisation | PSI |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | experience and intellectual |
| Collaborator Contribution | leadership, experience and intellectual |
| Impact | None so far - two abstract submissions made |
| Start Year | 2021 |
| Description | PhD student in Clinical Trial Monitoring |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Creator of the projects and primary supervisor of this PHD student |
| Collaborator Contribution | The PhD student is giving intellectual input to the projects |
| Impact | none yet |
| Start Year | 2022 |
| Description | PhD student in Clinical Trial Monitoring |
| Organisation | University of Nottingham |
| Department | Nottingham Clinical Trials Unit (NCTU) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Creator of the projects and primary supervisor of this PHD student |
| Collaborator Contribution | The PhD student is giving intellectual input to the projects |
| Impact | none yet |
| Start Year | 2022 |
| Description | PhD student in electronic health records |
| Organisation | Institute of Cancer Research UK |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Developing PhD proposal and primary supervision (JC) and secondary supervision (MS, SL) |
| Collaborator Contribution | One secondary supervisor is from ICR (NJ) and one from Birmingham (HM) |
| Impact | Published protocol -- see outputs ("Registered systmatic review: Monitoring strategies for clinical intervention studies") |
| Start Year | 2020 |
| Description | PhD student in electronic health records |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Developing PhD proposal and primary supervision (JC) and secondary supervision (MS, SL) |
| Collaborator Contribution | One secondary supervisor is from ICR (NJ) and one from Birmingham (HM) |
| Impact | Published protocol -- see outputs ("Registered systmatic review: Monitoring strategies for clinical intervention studies") |
| Start Year | 2020 |
| Description | SPIRIT-Routine |
| Organisation | University College Cork |
| Country | Ireland |
| Sector | Academic/University |
| PI Contribution | 10,000 Euro grant from Irish HRB Trials Methodology Research Network to UC Cork to develop extension to SPIRIT (Standard Protocol Items for Randomised Trials) checklist for clear use of routinely collected health data (RCHD). CTU on committee. Many other universities involved. |
| Collaborator Contribution | None yet |
| Impact | None yet |
| Start Year | 2021 |
| Description | Secondment to NHS Digital |
| Organisation | NHS Digital |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | expertise and intellectual input |
| Collaborator Contribution | expertise and intellectual input |
| Impact | outputs expected 2021 |
| Start Year | 2020 |
| Description | TMRP TCWG Data Quality and Monitoring topic group |
| Organisation | University of Nottingham |
| Department | Nottingham Clinical Trials Unit (NCTU) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | leadership, expertise and intellectual input |
| Collaborator Contribution | expertise and intellectual input |
| Impact | outputs paper submitted mulitdisciplinary - trial statisticians, trial managers, data managers, data scientists, researchers |
| Start Year | 2020 |
| Description | Task and Finish Monitoring Group |
| Organisation | UK Clinical Research Collaboration |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Leadership, expertise and intellectual input |
| Collaborator Contribution | expertise and intellectual input |
| Impact | paper DOI: 10.1186/s13063-021-05225-5, handbook of monitoring available at ukcrc-ctu.org.uk/guidance-for-ctus/ multidisciplinary - researchers, data scientists, trial managers, monitors |
| Start Year | 2019 |
| Description | Training the next generation of Indian clinical trialists |
| Organisation | Christian Medical College, Vellore |
| Country | India |
| Sector | Academic/University |
| PI Contribution | Have provided guidance, contributed to each aspect of the development of an Indian MSc (details below), visitied both Indian sites and taught on the MSc |
| Collaborator Contribution | Worked together to develop and deliver an Indian MSc - details below Submitted a BC grant application to support exchanges of students and staff which was successful |
| Impact | Secured funding from British Council - Going Global Partnerships India - Collaborative Grant Launch in Sept 2022 a two-year MSc in Clinical Research with specialisation in Clinical Trials at THSTI, India. Twelve students have been enrolled in the first batch. The degree will be awarded by RCB India. Multidisciplinary - clinicians, statisticians, clinical trialists |
| Start Year | 2019 |
| Description | Training the next generation of Indian clinical trialists |
| Organisation | Translational Health Science And Technology Institute |
| Country | India |
| Sector | Public |
| PI Contribution | Have provided guidance, contributed to each aspect of the development of an Indian MSc (details below), visitied both Indian sites and taught on the MSc |
| Collaborator Contribution | Worked together to develop and deliver an Indian MSc - details below Submitted a BC grant application to support exchanges of students and staff which was successful |
| Impact | Secured funding from British Council - Going Global Partnerships India - Collaborative Grant Launch in Sept 2022 a two-year MSc in Clinical Research with specialisation in Clinical Trials at THSTI, India. Twelve students have been enrolled in the first batch. The degree will be awarded by RCB India. Multidisciplinary - clinicians, statisticians, clinical trialists |
| Start Year | 2019 |
| Description | UCL - Astra Zeneca: RAMPART Trial - Main Collaboration Agreement |
| Organisation | AstraZeneca |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | MRC CTU at UCL has led on the design of this trial, is leading on all aspects of trial conduct and will lead on all aspects of trial analysis, reporting and the dissemination of results. |
| Collaborator Contribution | Astra Zeneca have agreed to provide USD$22,000,000 to support the cost of the trial. They are also providing free trial drugs to sites (including cost of distribution). |
| Impact | No outputs to date. |
| Start Year | 2018 |
| Description | UCL - Kidney Cancer UK - RAMPART Trial |
| Organisation | Kidney Research UK |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | MRC CTU at UCL has led on the design of the RAMPART trial, is leading on all aspects of trial conduct and will lead on all aspects of trial analysis, reporting and the dissemination of results. |
| Collaborator Contribution | Kidney Cancer UK peer-reviewed and approved the RAMPART trial, consequently the trial was adopted onto the NCRI trials portfolio. Kidney Cancer UK have agreed to provide funding to support patient-centred activities. |
| Impact | No outcomes to date |
| Start Year | 2018 |
| Description | UKCRC Task and Finish Group for Monitoring |
| Organisation | UK Clinical Research Collaboration |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Initiated and developed the nationwide monitoring group |
| Collaborator Contribution | Will bring nationwide experience and engagement on future projects |
| Impact | (None yet) |
| Start Year | 2019 |
| Description | ongoing collaboration in clinical trial monitoring with MHRA |
| Organisation | Medicines and Healthcare Regulatory Agency |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | intellectual and experience |
| Collaborator Contribution | intellectual and experience |
| Impact | multi-disciplinary output Introduction to monitoring handbook to be found ukcrc-ctu.org.uk/guidance-for-ctus/ |
| Start Year | 2021 |
| Description | 5th TMRP/UKTMN webinar programme (Oct 2022) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | I was invited to talk about data integrity of healthcare systems data, the regulatory landscape around it, and how data can be assessed for integrity. This was delivered online to the audience of their webinar programme. The audience was approximately 30-50 clinical trialists such as trial managers, statisticians, and researchers, who reported that they had a better understanding and increased interest in this area of data quality, and the implications for running trials using such data. |
| Year(s) Of Engagement Activity | 2022 |
| URL | http://www.methodologyhubs.mrc.ac.uk/files/6216/6792/4206/TMRP_Webinar_-_Data_Integrity_HDRUK.pdf |
| Description | BHF Data Science Centre monthly seminar (Nov 2022) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | I was invited to talk about data integrity of healthcare systems data that are used in clinical trials, the regulatory landscape around it, and how data can be assessed for integrity. This was delivered online to the BHF Data Science Centre audience of their monthly seminar programme. The audience was approximately 50 and included data scientists, trialists, cardiovascular researchers and clinicians, who reported they had a better understanding and increased interest in this area of data quality, and the implications of using such data. There is a further 52 views of the recorded seminar on YouTube. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://youtu.be/OzQeMUUG7tQ |
| Description | Behind the Headlines committee |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | As member of Before the Headlines panel, Matt Sydes has commented on advanced versions of a number of press releases which are then quoted by journalists in national newspapers. The comments are usually to enhance the understanding, or temper the expections, of the general public when news stories are picked up which may not be easily misinterpreted. |
| Year(s) Of Engagement Activity | 2022,2023 |
| URL | https://www.sciencemediacentre.org/working-with-us/for-journalists/headlines-for-journalists/ |
| Description | Being part of expert panel for HRA 'Make it public' annual conference |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | The how, why and what of communicating with participants: a panel discussion between: Katie Gillies, University of Aberdeen Amelia Hursey, Parkinson's UK Lynn Laidlaw, Public Contributor Annabelle South, University College London |
| Year(s) Of Engagement Activity | 2021 |
| Description | Clinical Trial Monitoring Webinar |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | 200 people interested in or responsible for clinical trial monitoring attended the 4 hour workshop |
| Year(s) Of Engagement Activity | 2021 |
| Description | Data-enabled trials at British Society for Heart Failure Investigators Network Virtual Research Meeting |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Matt Sydes gave an invited talk to British Society for Heart Failure Investigators Network Virtual Research Meeting. Aimed primarily at clinicians but many patients and public representatives in the audience. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://vimeo.com/575891014/c0ab47d7ef |
| Description | Discussion sessions with MHRA about data integrity of healthcare systems data |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Two-part discussions about how to demonstrate data integrity for healthcare systems datasets held by NHS Digital. Has led to report, MHRA updating position and future research. |
| Year(s) Of Engagement Activity | 2021 |
| Description | EU-PEARL workshop on non-concurrent controls |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | International workshop on the controversial area of using on patients in a platform protocol not randomised concurrently to the trial. M Parmar and M Sydes contributed presentations and panel discussions. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.youtube.com/watch?v=nYl-lHtVwxA&ab_channel=EU-PEARL |
| Description | Evidence of usefulness of clinical trial Remote Monitoring |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | I was invited to give a talk ont he evidence of the usefulness of remote monitoring to stimulate a 30 minute discussion at a national clinical trial monitoring meeting |
| Year(s) Of Engagement Activity | 2022 |
| Description | Expert panelist on HDRUK Data Use Register standards webinar |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Invited expert panelist on an HDRUK webinar accompanying the launch of a White paper setting out Data Use Register standards. |
| Year(s) Of Engagement Activity | 2022 |
| Description | HDR UK Bimonthly Science webinar (18 Oct 2022) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | I was invited to talk about data integrity of healthcare systems data, the regulatory landscape around it, and how data can be assessed for integrity. Audience ~50-100 healthcare researchers, data scientists, patient group representatives, data providers, staff from industry and commercial contract research organisations. The audience reported that they had a better understanding and increased interest in this area of data quality, and the implications for running trials using such data. Afterwards, I was approached by a data provider to find out more about data integrity assessments. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.hdruk.ac.uk/events/bimonthly-science-webinar-september/ |
| Description | Invited speaker at National Cancer Research Institute |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | I was invited to speak at an NCRI meeting about Health Data to raise the issues around using healthcare systems data in cancer trials. The audience comprised members of the NCRI groups (20-25) and the chair was leading the newly formed strategy group on Health Data. They reported that they had a better understanding and increased interest in the area of health data including the barriers to their use in trials. I was invited to participate further by inputting into and reviewing their draft strategy paper. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Invited speaker for NHS DigiTrials Team Event: Clinical Trials Perspective |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Other audiences |
| Results and Impact | A brief introduction to clinical trials and the role of the clinical trial secondees given to the NHS DigiTrials programme team at NHS Digital, on 8th July 2021. The aim was to increase the team's knowledge and awareness of clinical trials: the lifecycle such as planning and conduct activities, and the benefits of including clinical trial secondees in the programme team. The key impacts were better understanding of the complexities of trial planning, setup and conduct, and where the DigiTrials services may help, and increased recognition of the importance of users' feedback on service development, especially from the secondees. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Invited speaker to NHS DigiTrials Away Day: Clinical Trials 101 - an introduction to clinical trials. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Other audiences |
| Results and Impact | One hour presentation and Q&A introducing clinical trials to the NHS DigiTrials Programme team at NHS Digital on 16th Sep 2021. Covered basic concepts such as phases of clinical development, the pathway of a Phase 3 CTIMP, and principles of Good Clinical Practice. Key impacts include: greater understanding by audience of clinical trial pathways, types of trials, context of DigiTrials services, and Good Clinical Practice and how it relates to the programme's work. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Keynote for Glasgow Clinical Trials Collaborative annual meeting |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | Keynote note presentation by Matthew Sydes for on Data-enabled trials at Glasgow Clinical Trials Collaborative annual meeting |
| Year(s) Of Engagement Activity | 2022 |
| Description | Keynote for UKCRC ISOG |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation by Matthew Sydes (Nov-2022) to UKCRC IS and Data Management Leads national meeting on Data-Enabled Trials and implications for data management |
| Year(s) Of Engagement Activity | 2022 |
| Description | Kick-off meeting: Clinical Practice Research Datalink as trial data (Sep 2022) |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Professional Practitioners |
| Results and Impact | I was invited to talk to the newly formed working group at CPRD ("CPRD as trial data") about data integrity, the regulatory landscape, and how data such those held by CPRD can be assessed for integrity. The audience comprised 10-12 staff at CPRD in the working group, and they all reported a better understanding of why data needs to be assessed and how. The talk provided the group with guidance on future next steps for recording the provenance and integrity of CPRD data. |
| Year(s) Of Engagement Activity | 2022 |
| Description | NIHR workshop on complex innovative trials |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | M Sydes member of panel discussion alongside MHRA, HRA and UKCRC CTU network representatives at this national workshop. Good discussions. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Patient workshop on use on healthcare systems data in clinical trials |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | Workshop for patients and the public on using healthcare systems data (routinely-collected healthcare data) in the STAMPEDE trial. Organised by Kate Sturgeon and Matt Sydes. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Podcast episode about sharing results with trial participants |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | Clinical trials depend on people volunteering to take part, often at increased risk or inconvenience. Previous research shows that most trial participants want to know what the trial eventually finds, but that many never get to find this out. In this episode we explore why sharing results with participants is important, based on findings from the Show RESPECT study. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://soundcloud.com/user-110325996-105034477/sharing-results-of-clinical-trials-with-participants... |
| Description | Podcast episode about sharing results with trial participants (episode 2) |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | We have an ethical obligation to offer results to trial participants. This podcast episode explores the challenges of sharing results and talks about the best ways of communicating results from an ovarian cancer trial and reflects on what should be the next steps to ensure that all trial participants find out about the results. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://soundcloud.com/trial-talk-podcast/sharing-results-of-clinical-trials-with-participants-part-... |
| Description | Podcast for registrars about challenges in getting funding for clinical trials |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Podcast episode for "sOOPR- a Fellow's guide to Out of Programme research": run by BJCA and supported by the BHF Clinical Research Collaborative. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.youtube.com/watch?v=aKG4xvpJbiY |
| Description | Presentation for ESMO young oncologists |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Invited online presentation by Matthew Sydes at pre-conference session for European Society of Medical Oncology (ESMO) 2023 Young Oncologists "HowTo" session: How to understand and apply statistical methods |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation on implementation of platform protocols at WHO IMPAACT workshop on post-natal prophylaxis |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Workshop of professions and patients to reach design for future trial. Presented an implementation expert on one of the approaches being considered. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Presentation on mapping current clinical trial monitoring practice against the aims of monitoring |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | I was asked to give a talk at a national meeting of the UK clinical trial monitoring community on work to map current practices in the monitoring of clinical trials against the aims of monitoring |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation to CCTG about implementing platform protocols |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Invited presentation for Canadian Cancer Trials Group (CCTG) by Matthew Sydes on "Better clinical trials through methodology: Implementation of MAMS platform protocols" t |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation to Dutch Clinical Oncology Research Group |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Online presentation by Matthew Sydes (Nov-2022) to Dutch Clinical Oncology Research Group webinar on Improving practical implementation of MAMS platform protocols |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentations and panel members at Patient Engagement Open Forum (PEOF) 2021 -- co-project organized by PFMD, EUPATI and European Patients' Forum (EPF) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Public/other audiences |
| Results and Impact | Matt Sydes and Nuru Noor presented examples of involving patients in platform protocols at the PEOF 2021 online conference. More than 2000 people registered for the conference from multiple continents. Uncertain how many joined this parallel session. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://patientengagement.synapseconnect.org/resources/peof-2021-patient-engagements-needs-in-platfo... |
| Description | Session to inspire and find out if there was interest in a clinical monitoring group for statisticians |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | We led a session sat the NIHR statisticians annual meeting to inspire trial statisticians to be involved in clinical trial monitoring and then led a discussion on how the inclusion of statisticians into clinical trial monitoring could be facilitated. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Social media research promotion |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | I posted a request for collaborators who are using or planning to use routine healthcare systems data in their clinical trials. The request was to conduct data utility comparison studies (DUCkS) (also known as validation studies), with an incentive of receiving a crochet duck as a reward for doing so. The aim was to encourage more trialists to produce evidence of whether routine data can replace traditional trial-specific data collection for a range of different trial outcomes. The first tweet of my Twitter thread reached 23.9k views (to date) including professional colleagues, and the wider public. Staff from at least 6 trials have expressed interest in further collaboration. |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://twitter.com/drmakerbaker/status/1628122224971419665?s=20 |
| Description | Training Research Ethics Committees on the issues in platform protocols |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation by M Sydes on Education and training: platform protocols and RECs at EFPIA meeting on Complex Clinical Trials. Aimed at people who sit or or engage with Research Ethics Committees. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://www.efpia.eu/media/636521/day-2-s2-bo6-master-v2.pdf |
| Description | Trial conduct invited talk |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Invited talk to clinicians and statisticians about the importance of trial conduct and recent research in this area. Lively Q&A session afterwards. |
| Year(s) Of Engagement Activity | 2023 |
| Description | UKCRC National Annual monitoring meeting |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | I led a meeting across 2 days inviting those with news to talk to the UK clinical trial monitoring community |
| Year(s) Of Engagement Activity | 2021 |
| Description | talk about clinical trial monitoring |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | I gave a talk titled "Wishing you a light bulb moment in clinical trial monitoring" where I explained monitoring in a novel way and tried to help the audience reach a moment of understanding. |
| Year(s) Of Engagement Activity | 2021 |
| Description | talk on international clinical trials day invite by ECRIN "Recommendations on operational challenges of platform trials " |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | the day of talks was to inspire the conduct of clinical trials. There were 400 attendees from across the world. Our talk sparked questions and discussion. |
| Year(s) Of Engagement Activity | 2021 |