Adaptive Clinical Trials
Lead Research Organisation:
University of Cambridge
Department Name: UNLISTED
Abstract
Classically designing a clinical trial involves making assumptions about various attributes, such as the treatment effect, before any data are collected. The aim of our programme is to introduce novel designs that are more flexible. The rigidity of the classic design can lead to failed studies due to wrong assumptions such as using an optimistic treatment effect to limit the size of the study. Our novel designs will allow the use of accrued information in many ways; this includes stopping the study early for futility or efficacy, re-assessing the size of the study and recruiting more patients if need be altering dose choices during the study and identifying subgroups of patients who respond the best to treatment. Our overall goal is to minimise the number of people needed within a study whilst maintaining the statistical rigour needed to correctly answer the scientific questions.
Technical Summary
Clinical trials are considered the gold-standard study design when testing for a causal effect of a new treatment or intervention. There are, however, many challenges to be faced in the future. The high, and increasing, cost of clinical trials has caused the drug development process to become more and more expensive (DiMasi, Grabowski, and Hansen 2016), meaning new design and analysis methods to increase efficiency are greatly needed. The barriers to using adaptive clinical trials are lifting, which is leading to an increasing uptake (Hatfield et al. 2016). Members of my team are working on several current and future trials that are implementing novel methods. This portfolio of trials forms a strong basis for our future methodology research plans. I have the capacity, skills and track-record to push the methodology forward to tackle even more ambitious problems. These include dealing with patient heterogeneity, exploiting multivariate outcomes in dose-finding/ranging trials, using historical data, applying bandit methodology to improve patient benefit in trials, and conducting trials within large cohorts.
I have been successful in building links with industry with several ongoing collaborations and two postdoctoral positions jointly funded by GlaxoSmithKline (GSK) and AstraZeneca (AZ).
My proposed future work includes five main objectives:
1. proposing novel trial design and analysis approaches for patient stratification to predict treatment benefit;
2. developing multi-arm multi-stage methodology that can be applied to a broader range of trial designs and types of endpoint;
3. extending and further enhancing model-free and model-robust methodology for dose- finding and ranging trial designs;
4. improving the efficiency of trials within small populations;
5. using the richness of complex outcomes to give more informative inference.
I have been successful in building links with industry with several ongoing collaborations and two postdoctoral positions jointly funded by GlaxoSmithKline (GSK) and AstraZeneca (AZ).
My proposed future work includes five main objectives:
1. proposing novel trial design and analysis approaches for patient stratification to predict treatment benefit;
2. developing multi-arm multi-stage methodology that can be applied to a broader range of trial designs and types of endpoint;
3. extending and further enhancing model-free and model-robust methodology for dose- finding and ranging trial designs;
4. improving the efficiency of trials within small populations;
5. using the richness of complex outcomes to give more informative inference.
Organisations
- University of Cambridge (Lead Research Organisation)
- AstraZeneca (United Kingdom) (Collaboration)
- Cancer Research UK Cambridge Institute (Collaboration)
- Roche Pharmaceuticals (Collaboration)
- CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST (Collaboration)
- Medical Research Council (MRC) (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- UNIVERSITY OF CAMBRIDGE (Collaboration)
People |
ORCID iD |
Publications
Yiu S
(2018)
Clustered multistate models with observation level random effects, mover-stayer effects and dynamic covariates: modelling transition intensities and sojourn times in a study of psoriatic arthritis.
in Journal of the Royal Statistical Society. Series C, Applied statistics
Related Projects
| Project Reference | Relationship | Related To | Start | End | Award Value |
|---|---|---|---|---|---|
| MC_UU_00002/2 | 01/12/2016 | 31/03/2024 | £3,696,000 | ||
| MC_UU_00002/3 | Transfer | MC_UU_00002/2 | 01/12/2016 | 31/08/2020 | £2,836,000 |
| MC_UU_00002/4 | Transfer | MC_UU_00002/3 | 01/12/2016 | 31/03/2024 | £4,663,000 |
| Description | AIM-HY |
| Amount | £43,679 (GBP) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2015 |
| End | 12/2019 |
| Description | EPAD- |
| Amount | € 654,000 (EUR) |
| Funding ID | 115736 |
| Organisation | European Commission |
| Department | Innovative Medicines Initiative (IMI) |
| Sector | Public |
| Country | Belgium |
| Start | 04/2015 |
| End | 03/2020 |
| Description | HTMR Network Award |
| Amount | £3,071 (GBP) |
| Funding ID | N97 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2018 |
| End | 09/2018 |
| Description | INNODIA |
| Amount | € 500,000 (EUR) |
| Funding ID | 115797 |
| Organisation | European Commission |
| Department | Innovative Medicines Initiative (IMI) |
| Sector | Public |
| Country | Belgium |
| Start | 10/2015 |
| End | 09/2022 |
| Description | MBU grant |
| Amount | £17,059 (GBP) |
| Organisation | University of Edinburgh |
| Department | MRC DPFS Resoure Centre |
| Sector | Academic/University |
| Country | United Kingdom |
| Start | 11/2014 |
| End | 02/2017 |
| Description | NIHR HTA (Epilepsy Nurse) |
| Amount | £52,826 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 04/2013 |
| End | 11/2015 |
| Description | NIHR XP grant |
| Amount | £10,597 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2015 |
| End | 03/2020 |
| Description | NIHR- Jonathan Mant |
| Amount | £85,434 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 04/2015 |
| End | 03/2020 |
| Description | AZ - Jodrell phase I |
| Organisation | AstraZeneca |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | We have only just initiated this collaboration so we have been shortlisting and trying to recruit |
| Collaborator Contribution | Shortlisting and recruiting |
| Impact | A trial called ATRIUM is being developed currently |
| Start Year | 2014 |
| Description | AZ - Jodrell phase I |
| Organisation | Cancer Research UK Cambridge Institute |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We have only just initiated this collaboration so we have been shortlisting and trying to recruit |
| Collaborator Contribution | Shortlisting and recruiting |
| Impact | A trial called ATRIUM is being developed currently |
| Start Year | 2014 |
| Description | AZ joint postdoc |
| Organisation | AstraZeneca |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | We have a joint position to look at Phase I dose escalation designs |
| Collaborator Contribution | Provide advice and scientific directin. |
| Impact | None yet. |
| Start Year | 2017 |
| Description | CTU joint positin |
| Organisation | Cambridge University Hospitals NHS Foundation Trust |
| Department | Cambridge Clinical Trials Unit |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | We have a joint position to work on dual agent dose escalation studies. |
| Collaborator Contribution | Scientific input |
| Impact | None yet |
| Start Year | 2017 |
| Description | Diabetes Research |
| Organisation | University of Cambridge |
| Department | Cambridge Institute for Medical Research (CIMR) |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Involved in multiple trials involving Il-2 dose/frequency finding |
| Collaborator Contribution | They ran the trial and gave the scientific steer |
| Impact | Publications and talks all completed/delivered |
| Start Year | 2011 |
| Description | Maxine's PhD |
| Organisation | GlaxoSmithKline (GSK) |
| Country | Global |
| Sector | Private |
| PI Contribution | I am the academic supervisor of this CASE award, the industry partners are within GSK. I give the main methodology direction of the project |
| Collaborator Contribution | Partners give scientific and practical guidance into the project |
| Impact | Several workshops delivered to GSK and AZ |
| Start Year | 2013 |
| Description | Polypill |
| Organisation | University of Cambridge |
| Department | Cambridge Institute of Public Health |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Co-applicant on program grant, developing trial design with research team. |
| Collaborator Contribution | Scientific direction and running trial |
| Impact | Unfortunately this grant terminated as the trial was too difficult to implement in the time alloted |
| Start Year | 2011 |
| Description | Roche phase I trial design |
| Organisation | Roche Pharmaceuticals |
| Country | Global |
| Sector | Private |
| PI Contribution | We have engaged with industry to try and implement methods in practice. We have had some meetings and some presentations but also we have some joint work ongoing to help implement the PIPE design methodology |
| Collaborator Contribution | The partners have listened and are committed to trying methods out in practice. Currently one of the their phase I trial designs is using the dual-agent design PIPE in one of their early phase trials (ClinicalTrials.gov Identifier: NCT02760797). |
| Impact | Two trials were implemented and the results are in Roche. |
| Start Year | 2014 |
| Description | WRAP study |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Human Nutrition Research Group |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Trial design expertise and how to handle missing data |
| Collaborator Contribution | Scientific direction and running the trial |
| Impact | Paper accepted and work complete |
| Start Year | 2012 |
| Title | GROUPSEQ: Stata module providing functions to determine group sequential trial designs |
| Description | A selection of functions to determine the boundaries and sample size required by several common group sequential designs, for two-arm trials with continuous outcome variables. |
| Type Of Technology | Software |
| Year Produced | 2017 |
| Impact | Several trial statisticians and methodologists have subsequently been in contact to ask for further information around the design of group sequential clinical trials, particularly in Stata. |
| URL | https://ideas.repec.org/c/boc/bocode/s458345.html |
| Title | MVTNORM: Stata module to work with the multivariate normal and multivariate t distributions |
| Description | A set of commands that allow users to compute the distribution function, density, equi-coordinate quantiles, and random vectors of the multivariate normal and multivariate t distributions. Any non-degenerate cases of the multivariate normal and multivariate t distributions can be worked with, along with a particular class of non-central multivariate t distributions. The commands are written in a combination of Stata and Mata for speed. |
| Type Of Technology | Software |
| Year Produced | 2017 |
| Impact | MVTNORM has subsequently allowed the creation of the GROUPSEQ module for designing group sequential clinical trials. |
| URL | https://ideas.repec.org/c/boc/bocode/s458043.html |
| Description | A day in the life blog post - David Robertson |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Other audiences |
| Results and Impact | 'A day in the life' blog post for the BSU website written by Senior Research Associate, David Robertson, giving audiences a glimpse into his role at the BSU. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://www.mrc-bsu.cam.ac.uk/blog/a-day-in-the-life-of-a-senior-statistician-david-robertson/ |
| Description | A day in the life blog post - Nina Deliu |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Other audiences |
| Results and Impact | 'A day in the life' blog post for the BSU website written by Research Associate, Nina Deliu, giving audiences a glimpse into her role at the BSU. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://www.mrc-bsu.cam.ac.uk/blog/a-day-in-the-life-of-a-statistician-nina-deliu/ |
| Description | A day in the life blog post - Sarah Dawson |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Other audiences |
| Results and Impact | 'A day in the life' blog post for the BSU website written by Statistician, Sarah Dawson, giving audiences a glimpse into her role at the BSU. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://www.mrc-bsu.cam.ac.uk/blog/a-day-in-the-life-of-a-statistician-sarah-dawson/ |
| Description | Adaptive Designs Talk at PSI conference |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This talk raised the awareness of the Hub Network activities in adaptive trial designs. There was some discussion of the methods and discussion about being available for consultative purposes. No notable impacts |
| Year(s) Of Engagement Activity | 2013 |
| Description | Adaptive Designs symposium at the Institute of Psychiatry |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | There was some interesting debates about adaptive designs Raised our visibility in Psychiatry |
| Year(s) Of Engagement Activity | 2013 |
| Description | Adaptive designs training course at Pavia University, Italy |
| 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 | We gave a 3 day training course on adaptive trial designs with practicals in R. |
| Year(s) Of Engagement Activity | 2017 |
| Description | Armitage Lectures |
| 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 | Annual workshop and lecture created and hosted by the MRC Biostatistics Unit, to honour the immense contributions of Professor Peter Armitage who was at the unit from 1947 to 1961, and whose work is recognised throughout the world as achieving a successful balance between methodological rigour and applied commonsense, to which all statisticians aspire. An eminent medical statistician visits for a week and works with members of the unit. The highlight is the Armitage Lecture, where more than 100 delegates attend. This event raises the unit research profile and creates new collaborations. |
| Year(s) Of Engagement Activity | 2012,2013,2014,2015,2016,2017 |
| URL | https://www.mrc-bsu.cam.ac.uk/news-and-events/armitage-lectureships-and-workshops/ |
| Description | BSU Open Day |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Schools |
| Results and Impact | Unit held open day as part of MRC Festival of Medical Research. The aim of the open day was to welcome secondary school students and members of the general public to come to the unit, find out about the research the unit does, and to take part in activities that illustrate BSU research, with the overall theme being 'Fun with statistics'. An open day of this format was a first for the unit and overall it was a very successful event. There were 40 attendees over a 4 hour event. All attendees pre-booked and were split into 4 groups for a 1 hour session comprising of an introduction, participation in hands-on activities, and a brief careers talk. The small groups and length of session allowed for quality engagement between the scientists and the audience. Feedback from the attendees was very positive, and the wider MRC Festival activities that took place in Cambridge demonstrated the benefits in delivering these types of events. |
| Year(s) Of Engagement Activity | 2016 |
| URL | http://www.mrc-bsu.cam.ac.uk/bsu-open-day-2016-why-are-statistics-important/ |
| Description | Big Biology Day 2018 |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Public/other audiences |
| Results and Impact | Presented 2x outreach activities for general public audiences (adults and children) on basic statistical methods that represent the research carried out by the BSU. Audiences enjoyed and engaged with activities, and altered views on the importance of statistics. Basic evaluation method carried out shows positive response from audience. |
| Year(s) Of Engagement Activity | 2018 |
| Description | Cambridge Science Festival |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Public/other audiences |
| Results and Impact | Each year BSU participate in Cambridge Science Festival - members of the general public explore and discuss issues of scientific interest and concern, through a series of different events. The festival also aims to raise aspirations by encouraging young people to consider a career in science, technology, engineering or mathematics. BSU take part over two full days - 'Science Saturday' and the 'Cambridge Biomedical Campus' day. The unit presents a stand with 4 - 5 interactive activities that each communicate a basic statistical method or idea, representing one of the four research themes in the unit. Each year a new activity is developed and delivered requiring scientific input from staff and students across the unit. Over the two days, BSU engage with approximately 500 adults and children who visit the festival. |
| Year(s) Of Engagement Activity | 2012,2013,2014,2015,2016,2017 |
| URL | http://www.sciencefestival.cam.ac.uk/ |
| Description | Cambridge Science Festival 2019 |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Public/other audiences |
| Results and Impact | Stand at Cambridge Science Festival 2019, presenting two interactive hands-on activities developed by researchers across the BSU; one explaining probability and risk, and the other on precision medicine. Reaching out to 500+ audience members over 1 day. |
| Year(s) Of Engagement Activity | 2019 |
| Description | Contributed talks at the 18th INFORMS Applied Probability Conference |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | SV gave contributed talks at the 18th INFORMS Applied Probability Conference and the 7th Greek Stochastics meeting. Talk entitled "Novel bandit-based solutions for practical stochastic scheduling problems". |
| Year(s) Of Engagement Activity | 2015 |
| URL | http://www.stochastics.gr/meetings/eta/ |
| Description | Dose finding talk (Charleston) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Talk sparked a discussion on various dose-ranging aspects No immediate impacts |
| Year(s) Of Engagement Activity | 2014 |
| Description | Dose ranging talk (Cambridge) invited by the Cambridge Discussion Group |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | Talk sparked a debate about these methods. Made some industry links within Roche and Astra Zeneca |
| Year(s) Of Engagement Activity | 2014 |
| Description | FameLab 2021 |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Public/other audiences |
| Results and Impact | Martin Law reached the Cambridge final of FameLab 2021 competition, describing his work in 3 minutes to a general public audience. |
| Year(s) Of Engagement Activity | 2021 |
| Description | I'm a Scientist, Stay at Home |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Schools |
| Results and Impact | PhD student Martin Law took part in online chat room activity, I'm a Scientist, Stay at Home, chatting with secondary school students about maths and statistics and answering their questions. |
| Year(s) Of Engagement Activity | 2020 |
| URL | https://www.mrc-bsu.cam.ac.uk/blog/a-window-into-the-world-of-a-statistician/ |
| Description | Invited presentation at an early phase clinical conference (Paris) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | I presented a novel clinical trial design on dual-agent dose escalation, there was a lot of interest from academics and industry. Since then I have worked closely with a member of Roche pharmaceuticals on how to implement these methods in practice. |
| Year(s) Of Engagement Activity | 2015 |
| Description | Invited talk at CLDAG 2017 conference |
| 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 an invited speaker to this international statistical conference. I spoke about adaptive dose ranging trial designs. |
| Year(s) Of Engagement Activity | 2017 |
| Description | Invited talk at the PSI meeting on Extrapolation |
| 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 was invited to give a talk on using historical data in trial inference and design. |
| Year(s) Of Engagement Activity | 2017 |
| Description | Invited talk for the Breathlessness conference (Cambridge) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Adrian Mander gave a presentation on the various ways to adapt clinical trials to the area of palliative and end of life care. There has been numerous discussions since the talk by email with plans to produce a paper introducing this area to the wider audience undertaking these challenging trials. |
| Year(s) Of Engagement Activity | 2015 |
| Description | Invited talk on early phase clinical trial designs (London) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | 80 members of clinical trials units attended a workshop run by the NCRI, the talk on early phase designs was aimed at changing practice and how we design phase I trials. |
| Year(s) Of Engagement Activity | 2015 |
| Description | Invited to give a departmental seminar on adaptive designs (Norwich) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Around 30 members of the clinical trials unit attended my talk on adaptive clinical trials, there was a great deal of interest and promises of future collaboration as there was a recognition that these methods will be needed in the near future |
| Year(s) Of Engagement Activity | 2015 |
| Description | NCRI talk on phase I trials (Liverpool) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | There was some debate and discussion. None so far but this was the start of raising the awareness of better trials in oncology |
| Year(s) Of Engagement Activity | 2012 |
| Description | Nuffield Placement Scheme |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Other audiences |
| Results and Impact | Statistician, Michael Grayling, took part in the Nuffiled Placement Scheme - supervising two A-Level students on a four week work experience placement at the Unit, both working on separate data analysis projects. Placements provided valuable experience for the students and helped them to understand the importance of statistics in clinical medicine. Both students have continued studying for A-Levels in maths and science subjects and plan to apply to study at University. |
| Year(s) Of Engagement Activity | 2017 |
| URL | http://www.nuffieldfoundation.org/nuffield-research-placements |
| Description | Nuffield Placement Scheme 2018 |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Schools |
| Results and Impact | 3x students (aged 16-17, from regional schools) currently studying A-Levels took part in four week work experience placement at the Unit with aim of inspiring next generation of scientists. Each student was supervised by a different post-doc researcher (Mary Fortune. Michael Grayling and Kirsty Rhodes) and each took on a different statistical based project which contributed to BSU research. Students produced research poster and report at end of placement which will contribute to University applications and further career development. Valuable supervising and engagement experience for BSU post-doc researchers. |
| Year(s) Of Engagement Activity | 2018 |
| Description | Oral presentation at the 23rd London Stata Users Group Meeting |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presented a talk entitled "Group sequential clinical trial designs for normally distributed outcome variables". |
| Year(s) Of Engagement Activity | 2017 |
| URL | http://www.timberlake.co.uk/2017-stata-user-group-abstracts |
| Description | Oral presentation at the Adaptive Designs and Multiple Testing Procedures Workshop |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presented a talk entitled "A two-stage Fisher exact-test for multi-arm trials with binary endpoints". |
| Year(s) Of Engagement Activity | 2017 |
| URL | https://www.mrc-bsu.cam.ac.uk/event/adaptive-designs-multiple-testing-procedures-workshop-2017/ |
| Description | Oral presentation at the CEN-ISBS 2017 Joint Conference on Biometrics and Biopharmaceutical Statistics |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presented a talk, in a contributed session, entitled "Do single-arm trials have a role in drug development plans incorporating randomised trials?". |
| Year(s) Of Engagement Activity | 2017 |
| URL | http://cenisbs2017.org/ |
| Description | Phase I course in dose-escalation adaptive designs at UCL |
| 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 | This was a two day training course aimed at statisticians in early phase designs. There were also regulators at this meeting. |
| Year(s) Of Engagement Activity | 2017 |
| Description | Poster presentation at the 38th Annual Conference of the International Society of Clinical Biostatistics |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presented a poster entitled "Admissible multi-arm stepped-wedge cluster randomized trial designs". |
| Year(s) Of Engagement Activity | 2017 |
| URL | http://iscb2017.info/ |
| Description | Poster presentation at the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presented a poster entitled "Blinded and unblinded sample size re-estimation procedures for stepped wedge cluster randomised trials". |
| Year(s) Of Engagement Activity | 2017 |
| Description | Poster presentation at the Current Developments in Cluster Randomised Trials and Stepped Wedge Design workshop |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presented a poster entitled "Design of an adaptive cluster randomised crossover trial, with application to the STRIVE trial". |
| Year(s) Of Engagement Activity | 2017 |
| Description | Research Design Service (LONDON) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | I was invited to talk about adaptive clinical trials as part of a workshop of talks. There is a call for novel designs and my talk covered various methods that can be used to make trials more efficient |
| Year(s) Of Engagement Activity | 2015 |
| Description | STEM Ambassador - Martin Law |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Schools |
| Results and Impact | PhD Student, Martin Law, is a STEM Ambassador - participates in at least one STEM activity per year (statistics workshops for schools in 2017). |
| Year(s) Of Engagement Activity | 2017 |
| Description | Statistical analysis for weight-loss trial (WRAP) |
| 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 | Media (as a channel to the public) |
| Results and Impact | Programme Leader Track, Adrian Mander, was co-author on peer-review publication in The Lancet on weight-loss trial (published April 2017). Paper received various local and national press attention, including article in The Guardian |
| Year(s) Of Engagement Activity | 2017 |
| URL | https://www.theguardian.com/lifeandstyle/2017/may/04/give-overweight-patients-a-year-of-weight-loss-... |
| Description | Talk about adaptive enrichment designs (Institute of Cancer Research |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | We had a day long discussion about various potential collaborations There were no massive impacts, a similar study was planned in their institute but it was too late to help improve it. |
| Year(s) Of Engagement Activity | 2014 |
| Description | Talk at Clinical Trials in Small Populations workshop |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | SV was co-organiser of worksop, gave a tutorial on `Response-adaptive randomisation' during Day 1 and also contributed to one of the talks during Day 2 entitled 'Bringing patient population size into clinical trial design using response-adaptive randomisation'. |
| Year(s) Of Engagement Activity | 2015 |
| Description | Talk at Lancaster University - Methodological work to make bandit models suitable to design (and improve) multi-armed clinical trial |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | SV invited speaker at workshop that gathered worldwide experts on ''bandit problems" (reinforcement learning bandits, restless bandits, non-parametric bandits, Bayesian bandits, etc., ) to discuss recent methodological advances and applications. SV spoke about recent methodological work to make bandit models suitable to design (and improve) multi-armed clinical trials. |
| Year(s) Of Engagement Activity | 2016 |
| Description | Talk at the local RSS NW group |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Professional Practitioners |
| Results and Impact | A review talk on the multiple bandit-based designs publications of Sofia Villar |
| Year(s) Of Engagement Activity | 2016 |
| Description | Talk on adaptive designs to Astra Zeneca |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | There was much interest in the methods and raised awareness of our group to the company Since this talk we have secured a data sharing agreement and collaboration. There are also 3 AZ post-docs that we have been linked with |
| Year(s) Of Engagement Activity | 2013 |
| Description | Teaching at BAYES 2018: Bayesian Biostatistics Workshop |
| 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 | Maxine Bennett was course leader at BAYES 2018: Bayesian Biostatistics on Bayesian approaches to incorporate historical data into clinical trials. Course attracted over 70 attendees from UK and internationally. Led to Maxine being asked to give same course at AstraZeneca. |
| Year(s) Of Engagement Activity | 2018 |
| Description | Workshop provision at the Society for Social Medicine 61st Annual Scientific 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 | Assisted in the organisation and delivery of a workshop entitled "Novel trial designs and analytical methods for evaluating complex public health interventions: a discussion", in collaboration with members of the MRC Lifecourse Epidemiology Unit. |
| Year(s) Of Engagement Activity | 2017 |