Stevens, Natasha;
Taheri, Shiva;
Grossi, Ugo;
Emmett, Chris;
Bannister, Sybil;
Norton, Christine;
Yiannakou, Yan;
(2023)
A study within a trial (SWAT) of clinical trial feasibility and barriers to recruitment in the United Kingdom – the CapaCiTY programme experience.
Research Square: Durham, NC, USA.
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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: 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. 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.
| Type: | Working / discussion paper |
|---|---|
| Title: | A study within a trial (SWAT) of clinical trial feasibility and barriers to recruitment in the United Kingdom – the CapaCiTY programme experience |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.21203/rs.3.rs-3406175/v1 |
| Publisher version: | https://doi.org/10.21203/rs.3.rs-3406175/v1 |
| Language: | English |
| Additional information: | © The Author 2024. This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). |
| Keywords: | clinical trial, feasibility, recruitment, barriers, RCT, SWAT, chronic constipation |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10204510 |
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