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

Abstract

Abstract Background: Recruitment is the Achilles heel of clinical trials. Failure to recruit the planned sample jeopardises reliability of results and wastes significant time and resources. Site feasibility assessments are a common tool employed by sponsors to assess a site’s recruitment potential and ability to undertake the trial protocol. The purpose of this study was to evaluate site feasibility procedures as a tool for predicting recruitment potential. Methods: We conducted site feasibility assessments with thirty-nine sites across the UK. Twenty-seven were selected to participate in the CapaCiTY programme: three randomised controlled trials (01; ISRCTN11791740; 16/07/2015, 02; ISRCTN11093872; 11/11/2015, 03; ISRCTN11747152; 30/09/2015) aiming to develop an evidence based adult chronic constipation treatment pathway. We compared site feasibility-based predicted recruitment rates with actual recruitment rates and conducted a telephone survey (n=24) to understand barriers to recruitment. Results: Sites failed to accurately predict their recruitment potential during site feasibility. Conducting site feasibility did not result in the trials recruiting the required sample. At the time of survey, 17% of sites in CapaCiTY01 were meeting recruitment targets, 83% were recruiting half or less of their target. Of these, 17% recruited no participants. In CapaCiTY02, 13% of sites were recruiting to target, 87% were recruiting half or less; of these, 25% recruited no participants. In CapaCiTY03, 14% of sites were recruiting to target, 86% recruited half or less of the target, of these 43% recruited none. The main barriers to recruitment were lack of resources, high workloads, lack of suitable participants and study design not being compatible with routine care. Conclusions: Improving the reliability of site feasibility assessment could potentially save hundreds of millions of pounds each year in failed research investments and speed up the time to delivery of new treatments for patients. We recommend 1) conducting site feasibility assessment at the pre-award stage; 2) investment in training researchers in conducting and completing site feasibility; 3) funders to include clinical trial feasibility specialists on peer review and grants panels; 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.