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Assessing the feasibility of complex and innovative trial designs


   School of Medicine

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  Dr Duncan Wilson  No more applications being accepted  Competition Funded PhD Project (Students Worldwide)

About the Project

Background: A wide variety of complex and innovative designs (CIDs), which move beyond the standard randomised controlled trial, have been proposed recently. These designs have the potential to make clinical trials faster and more efficient, thereby increasing the speed of drug development and delivering better treatments to patients sooner. The novelty of these designs, however, has led to substantial uncertainty about how feasible they are to run in practice. Perennial concerns about poor recruitment, adherence and follow-up in clinical trials may be further amplified when using complex designs, while features specific to CIDs such as interim analyses, multiple randomisations, biomarker guided stratification, and the adding or removal of treatment arms, contribute further uncertainty. A quantitative approach to modelling these complex designs and assessing their feasibility could help avoid expensive and time-consuming infeasible trials whilst identifying promising situations which warrant confident investment.

The studentship: The student will initially set out to understand the key attributes of a CID in relation to its feasibility, in consultation with trial managers, methodologists, and statisticians. Appropriate methods for modelling trial processes and outcomes will then be reviewed and extended to the case of CIDs, before being applied to two real trial case studies of CIDs in oncology. Three methodological questions will then be addressed: a) how should we use models of CIDs to inform their design, in terms of both simple (e.g. stop/go) and complex (e.g. trial process optimisation) trial design decisions; b) how should we use data from early phase, pilot, or historical trials to calibrate CID trial models and thereby improve their predictions; and c) how can we analyse CID models to better understand the key areas of uncertainty which should be targeted in early-phase / pilot work. Although a Bayesian framework may be particularly appropriate given the focus on prediction and decision making, a frequentist approach may also be explored. The fact that CIDs typically require simulation to determine their statistical properties suggests that the developed methods will be computationally demanding, and so the project will be underpinned by a focus on the implementation and dissemination of efficient, freely-available and well-documented software packages which will facilitate their application in practice.

Supervision: Day-to-day support will be provided by Dr Duncan Wilson of the Leeds Institute of Clinical Trials Research (LICTR), with expertise in the development and implementation of statistical methods in clinical trials. Co-supervision will be provided by Dr David Cairns, LICTR’s late-phase cancer trial division lead. Richard Hooper, Professor of Medical Statistics at the Centre for Clinical Trials Methodology, Queen Mary University of London, will provide additional advice and guidance.

Field work/placements: N/a

PPI: Patient involvement will help guide the development of the components of the CID models which focus on patient behaviour. Wider stakeholder engagement will include regular discussions with LICTR’s trial managers and statisticians to ensure the developed methods are relevant and easy to use.

Candidates should hold a first degree in mathematics, statistics, or similar; and/or a Masters degree in statistics, operational research, or similar.

HOW TO APPLY

You are applying for a PhD studentship from the MRC TMRP DTP. A list of potential projects and the application form is available online at:

http://www.methodologyhubs.mrc.ac.uk/about/tmrp-doctoral-training-partnership/

Please complete the form fully. Incomplete forms will not be considered. CVs will not be accepted for this scheme.

Please apply giving details for your first choice project. You can provide details of up to two other TMRP DTP projects you may be interested in at section B of the application form.

Before making an application, applicants should contact the project primary supervisor to find out more about the project and to discuss their interests in the research.

The deadline for applications is 4pm (GMT) 18 February 2022. Late applications will not be considered.

Completed application forms must be returned to: [Email Address Removed]

Informal enquiries may be made to [Email Address Removed]


Funding Notes

Studentships are funded by the Medical Research Council (MRC) for 3 years. Funding will cover tuition fees at the UK rate only, a Research Training and Support Grant (RTSG) and stipend (stipend to include London Weighting where appropriate). We aim to support the most outstanding applicants from outside the UK and are able to offer a limited number of bursaries that will enable full studentships to be awarded to international applicants. These full studentships will only be awarded to exceptional quality candidates, due to the competitive nature of this scheme.

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