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Improving the design, conduct, analysis and reporting of external pilot and feasibility studies


About This PhD Project

Project Description

NDORMS 2019/7

Randomised controlled trials provide the best evidence about the effectiveness (and harms) of health care interventions and are a crucially important part of the practice of evidence-based medicine. Randomised trials are often expensive and complicated to run. Because of this, researchers frequently conduct pilot and feasibility studies in advance of randomised trials assessing effectiveness. These pilot and feasibility studies help them to understand whether the future randomised trial can be successfully carried out, whether they should proceed with it, and if so how. Depending on the specific questions being addressed in these pilot and feasibility studies they may or may not be randomised.

The number of published reports of pilot and feasibility studies in the medical literature is increasing. There is also a growing body of literature about the methods used to conduct such studies and how they should be reported. For example, guidance was recently published on how to report randomised pilot and feasibility under the umbrella of CONSORT (Consolidated Standards of Reporting Trials), an initiative that focuses on producing such guidance for different sorts of randomised trials. The guidance is in the form of a checklist that offers a standard way for authors to prepare reports of trial findings and to allow readers to more clearly understand what was done and what was found. However, there is still a great deal of variability in the way pilot and feasibility studies are designed, conducted, and analysed, and quite a lot of uncertainty amongst the research community about how best to do this.

The aims of this project are to address important uncertainties in design, conduct, analysis and reporting of external pilot and feasibility studies. Such uncertainties include ways of determining the sample size for a pilot trial, the progression criteria for a main trial, methods of analysis, the inclusion of pilot trials in systematic reviews and better ways of improving reporting.

Details of Research Group:


The DPhil will be jointly supervised by Associate Prof Sally Hopewell and Susan Dutton, based at the Centre for Statistics in Medicine (CSM) and the Oxford Clinical Trials Research Unit (OCTRU), NDORMS, University of Oxford. The research group also includes Prof Sandra Eldridge, Director of the Pragmatic Clinical Trials Unit (Queen Mary University of London) who leads an international collaborative group working on pilot and feasibility studies.

• Associate Prof Sally Hopewell’s research interests are focused on the design, conduct and transparent reporting of randomised trials and systematic reviews and has published extensively in these areas. She has been instrumental in the development of key reporting guidelines such as the CONSORT Statement and PRISMA for Abstracts.

• Susan Dutton’s research interests are focused on the design, conduct, analysis and reporting of randomised controlled trials. She is a Senior Medical Statistician and the Lead Statistician for OCTRU and has extensive experience into phase I-IV randomised and non-randomised trials including external pilot and feasibility studies contributing to the design and ensuring that the conduct, analysis and reporting of the trials are carried out appropriately.

• Prof Sandra Eldridge’s research interest focus on cluster randomised trials, pilot and feasibility studies, and pragmatic trials more generally. She led the work to produce the CONSORT guidelines for pilot randomised trials, sits on various funding panels for the National Institute for Health Research and is a member of the Editorial Board for the BMC Pilot and Feasibility Studies Journal.

Training:


The Centre for Statistics in Medicine (www.csm.ox.ac.uk/) and Oxford Clinical Trials Research Unit (www.octru.ox.ac.uk/) are located in the Botnar Research Centre. CSM has more than 20 years’ experience in medical statistics and clinical trials. OCTRU, part of the CSM, is a fully registered UKCRC Clinical Trials Unit, involved in the design, conduct, analysis and reporting in both early and later phase clinical trials in surgery, musculoskeletal sciences, respiratory medicine, gastroenterology and oncology.

Training will be provided in relevant related research methodology, including evidence synthesis, handling and analysis of datasets, and statistical techniques. Attendance at formal training courses will be encouraged, and will include the one-week “Randomised Controlled Trials Course” run by CSM and courses in statistics as relevant.

In addition, courses from the Oxford Learning Institute and the Oxford University Computer Sciences on key skills for the completion of a successful DPhil thesis will be available. Additional on the job training opportunities will arise, and the supervisors will encourage the student to pursue such opportunities.

A core curriculum of lectures organized departmentally will be taken in the first term to provide a solid foundation in a broad range of subjects including epidemiology, health economics, and data analysis. Students will attend weekly seminars within the department and those relevant in the wider University. Students will be expected to present data regularly to the department, the research group and to attend external conferences to present their research globally.

Students will have access to various courses run by the Medical Sciences Division Skills Training Team and other departments (https://www.medsci.ox.ac.uk/study/skillstraining).

Further information:


Please contact: Associate Prof Sally Hopewell ().

How to apply:


The department accepts applications throughout the year but it is recommended that, in the first instance, you contact the relevant supervisors or the Graduate Studies Officer, Sam Burnell (), who will be able to advise you of the essential requirements.

Interested applicants should have or expect to obtain a first or upper second class BSc degree or equivalent, and will also need to provide evidence of English language competence. The application guide and form is found online (https://www.ox.ac.uk/admissions/graduate/applying-to-oxford/application-guide?wssl=1) and the DPhil or MSc by research will commence in October 2019.

For further information, please visit http://www.ox.ac.uk/admissions/graduate/applying-to-oxford.

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