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



To 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.



HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed.



Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers.



Target 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).



This 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%).



There 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.
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Stephen J
0000-0001-9000-8126
SJ
Walters
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Inês
I
Bonacho Dos Anjos Henriques-Cadby
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Oscar
O
Bortolami
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Laura
L
Flight
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Daniel
D
Hind
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Richard M
0000-0001-6710-5403
RM
Jacques
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Christopher
C
Knox
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Ben
B
Nadin
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Joanne
J
Rothwell
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Michael
M
Surtees
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Steven A
SA
Julious
D003362:Cost-Benefit Analysis / Q000191:economics; D006801:Humans; D015337:Multicenter Studies as Topic / Q000191:economics / Q000706:statistics & numerical data; D010352:Patient Dropouts / Q000706:statistics & numerical data*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000706:statistics & numerical data*; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000379:methods*; D006113:United Kingdom
Health Technology Assessment; Publicly funded; Randomised Controlled Trials; Retention; recruitment; review