A study within a trial (SWAT) of clinical trial feasibility and barriers to recruitment in the United Kingdom - the CapaCiTY programme experience

Background: The CapaCiTY programme includes three, multi-centre, randomised controlled trials aiming to develop an evidence based adult chronic constipation treatment pathway. The trials were conducted in the United Kingdom, National Health Service, aiming to recruit 808 participants from 26 March 2015 to 31 January 2019. Sites were selected based on their responses to site feasibility questionnaires (2014-2015), a common tool employed by sponsors to assess a site's recruitment potential and ability to undertake the trial protocol. Failure to recruit the planned sample jeopardises reliability of results and wastes significant time and resources. The purpose of this study was to investigate barriers to recruitment in 2017.

Methods: We conducted site feasibility assessments with thirty-nine sites prior to trial commencement. Twenty-seven were selected to participate in the CapaCiTY programme, twelve were deemed unsuitable. We compared site contracted recruitment rates with actual recruitment rates and conducted a telephone survey and analysis from 5 July to 7 December 2017 (n = 24) to understand barriers to recruitment. Three sites declined to participate in the survey.

Results: At the time of survey, 15% of sites in the CapaCiTY programme were meeting recruitment targets, 85% were recruiting half or less of their target. Of these, 28% recruited no participants. The main barriers to recruitment were lack of resources, high workloads, lack of suitable participants and study design not being compatible with routine care. Despite multiple strategies employed to overcome these barriers, the trials were eventually stopped due to futility, recruiting only 34% of the programme sample size.

Conclusions: Improving the reliability of site feasibility assessments could potentially save a substantial amount in failed research investments and speed up the time to delivery of new treatments. We recommend 1) investment in training researchers in conducting and completing site feasibility; 2) funders to require pilot and feasibility data in grant applications, with an emphasis on patient and public involvement in trial design; 3) conducting site feasibility assessment at the pre-award stage; 4) development of a national database of sites' previous trial recruitment performance; 5) data-driven site level assessment of recruitment potential.

Trial registration: ISRCTN11791740; 16/07/2015, ISRCTN11093872; 11/11/2015, ISRCTN11747152; 30/09/2015.