Method - Efficient and effective conduct of clinical trials

Lead Research Organisation: University College London

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.

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.

Organisations

Publications

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Bass EJ (2021) PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study. in Contemporary clinical trials

 
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 QualShare - Irish HBR Trials Methodology call
Amount € 10,000 (EUR)
Funding ID QualShare 
Organisation Trials Methodology Research Network 
Sector Private
Country Ireland
Start 03/2021 
End 04/2022
 
Description SPIRIT-EHR
Amount € 10,000 (EUR)
Organisation Trials Methodology Research Network 
Sector Private
Country Ireland
Start 03/2021 
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 08/2021 
End 09/2022
 
Description TMRP Doctoral Training Programme
Amount £2,518,806 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 08/2021 
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 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 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 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 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 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 submitted Feb-2022
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 submitted Feb-2022
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 submitted Feb-2022
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 submitted Feb-2022
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 Work ongoing but includes https://zenodo.org/record/6047155#.YiXW1fnP2Uk
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 Work ongoing but includes https://zenodo.org/record/6047155#.YiXW1fnP2Uk
Start Year 2021
 
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 Digital collaboration 
Organisation Health & Social Care Information Centre (HSCIC)
Country United Kingdom 
Sector Public 
PI Contribution Strategic and collaborative input
Collaborator Contribution Strategic and collaborative input
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 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 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 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 Expert panelist on HDRUK Data Use Register standards webinar 
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 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 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 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 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 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 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 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