Poor recruitment is a significant barrier to obtaining robust results from many clinical trials and among the top reasons why most trials fail. Pilot studies are increasingly common and advocated by funding bodies such as NIHR, many having a primary aim of providing information about recruitment rates for a definitive trial. However, there is no existing work examining how effective this strategy is and, in particular, the extent to which recruitment rates in pilot studies reflect recruitment rates in definitive trials. There are several reasons why recruitment rates may differ in pilot and definitive trials including selection of enthusiastic sites in the pilot study, the effort that can be expended on recruiting a smaller number of participants in such a study, changes in the environment between pilot and definitive trials, different populations, but this has never been comprehensively studied. Improved knowledge in this area will reduce research waste by ensuring that pilot studies are designed and interpreted so that their results can be used more effectively to decide whether to proceed with a definitive trial and how to improve recruitment.
What the studentship will encompass:
In this studentship, the student will focus on randomised external pilot studies (hereafter “pilot trials”), because these are the most common type of external pilot study and because recruitment methods are likely to be similar in these types of study and corresponding definitive trials they were designed to inform.
The student will address the following questions:
1. How similar or different are recruitment rates in pilot and definitive trials and what are the reasons for the differences (systematic review extracting data from the pilot and main trial and examining differences)?
2. How do trialists use the information from external pilot studies to estimate and/or improve recruitment rates in a definitive trial and what else guides their decision making in this area? (qualitative work)
3. What further tools might be useful in interpreting recruitment rates from a pilot trial? (methodology developed out of previous work and dependent on background of student but could, for example, include simulation making different assumptions about factors that might affect recruitment rates in definitive and pilot trials differently for a student with sufficient statistical background)
4. What guidance is needed for investigators? (discussion with funders plus Delphi study or other consensus method, leading to guidance development)
Primary supervisor: Rachel Phillips, QMUL. Co-supervisors: Lehana Thabane, McMaster University, Canada; Sandra Eldridge, (honorary contract, QMUL). Wider supervisory team to include Christine Bond (Aberdeen) and Sally Hopewell (Oxford) both members of the international Pilot and Feasibility Studies Collaboration that produced the CONSORT extension for pilot trials. Both Aberdeen and Oxford are part of TMRP.
Two- to six-week visit to McMaster University to understand the context of recruitment rates and pilot and feasibility studies in a different funding environment and participate in a forum on pilot and feasibility studies.
We will involve lay individuals interested in reducing research waste by addressing issues around recruitment, including those who have participated in trials, at all stages of the research, providing training and re-imbursement following INVOLVE guidelines. We expect the individuals to be particularly involved in the consensus process to develop guidelines for recruitment.
Candidates should have some experience and training in health research and clinical trials at the undergraduate or Masters level.
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:
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]