Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme

• Published in: BMJ open Vol. 7; no. 3; p. e015276
• Main Authors: Walters, Stephen J, Bonacho dos Anjos Henriques-Cadby, Inês, Bortolami, Oscar, Flight, Laura, Hind, Daniel, Jacques, Richard M, Knox, Christopher, Nadin, Ben, Rothwell, Joanne, Surtees, Michael, Julious, Steven A
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01-03-2017; BMJ Publishing Group
• Subjects: Cardiovascular disease; Catheters; Clinical trials; Cost analysis; Cost-Benefit Analysis - economics; Evidence-based medicine; Health technology assessment; Human subjects; Humans; Medical research; Multicenter Studies as Topic - economics; Multicenter Studies as Topic - statistics & numerical data; Older people; Participation; Patient Dropouts - statistics & numerical data; Patient Selection; Patients; Randomized Controlled Trials as Topic - economics; Randomized Controlled Trials as Topic - statistics & numerical data; Recruitment; Research Methods; Retention; Streptococcus infections; Technology Assessment, Biomedical - economics; Technology Assessment, Biomedical - methods; United Kingdom; United Kingdom > UK; Randomised Controlled Trials; Retention; recruitment; Publicly funded; Health Technology Assessment; review
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2016-015276

BackgroundSubstantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope.ObjectivesTo review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme.Data sources and study selectionHTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed.Data extractionInformation was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers.Main outcome measuresTarget sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data).ResultsThis review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43–2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79–97%).ConclusionsThere is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections.