Abstract
Background: Recruitment is the Achilles heel of clinical trials. Failure to recruit the sample size jeopardises the reliability of results and wastes a significant amount of 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 clinical trial protocol. The purpose of this study is to evaluate site feasibility procedures as a tool for predicting recruitment potential.
Methods: We conducted site feasibility with thirty-nine sites across the UK. Twenty-seven were selected to participate in the CapaCiTY (01/02/03) program; three randomised controlled trials aiming to develop an evidence based chronic constipation (CC) treatment pathway for adults. We compared site feasibilities predicted recruitment rates with actual recruitment rates and conducted a telephone survey to understand the barriers to recruitment.
Results: Sites did not accurately predict their recruitment potential during site feasibility. Conducting site feasibility did not result in the trials reaching the required sample size. At the time of survey, 17% of sites in CapaCiTY01 were meeting recruitment targets, 83% were recruiting half or less than half their target. Of these, 17% recruited no participants. In CapaCiTY02, 13% of sites were recruiting to target, 87% were recruiting half or less than half, of these, 25% recruited no participants. In CapaCiTY03, 14% of sites were recruiting to target, 86% recruited half or less than half the target, of these 43% recruited none. The main barriers to recruitment were lack of resources 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 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) sample size feasibility assessment based on country-specific disease prevalence and epidemiology data 4) funders to include clinical trial feasibility specialists on peer review and grants panels 5) development of a national database of sites previous trial recruitment performance.
Aim
The purpose of this study is to evaluate site feasibility procedures as a tool for predicting recruitment potential.