Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study

doi:10.1136/bmj.a2079

Published 13 November 2008, doi:10.1136/bmj.a2079
Cite this as: BMJ 2008;337:a2079

Research

Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study

Usha Menon, senior lecturer and consultant gynaecologist¹, Aleksandra Gentry-Maharaj, research fellow¹, Andy Ryan, database manager¹, Aarti Sharma, clinical research fellow¹, Matthew Burnell, statistician¹, Rachel Hallett, research fellow¹, Sara Lewis, research assistant¹, Alberto Lopez, consultant gynaecological oncologist², Keith Godfrey, consultant gynaecological oncologist², David Oram, consultant gynaecological oncologist³, Jonathan Herod, consultant gynaecological oncologist⁴, Karin Williamson, consultant gynaecological oncologist⁵, Mourad Seif, senior lecturer and consultant gynaecologist⁶, Ian Scott, consultant gynaecological oncologist⁷, Tim Mould, consultant gynaecological oncologist⁸, Robert Woolas, consultant gynaecological oncologist⁹, John Murdoch, consultant gynaecological oncologist¹⁰, Stephen Dobbs, consultant gynaecological oncologist¹¹, Nazar Amso, senior lecturer and consultant gynaecologist¹², Simon Leeson, consultant gynaecological oncologist¹³, Derek Cruickshank, consultant gynaecological oncologist¹⁴, Ali McGuire, professor of economics¹⁵, Stuart Campbell, professor and consultant obstetrician and gynaecologist¹⁶, Lesley Fallowfield, professor of psycho-oncology¹⁷, Steve Skates, biostatistician¹⁸, Mahesh Parmar, professor of medical statistics and epidemiology¹⁹, Ian Jacobs, professor of gynaecological oncology and consultant gynaecological oncologist¹

¹ Gynaecological Oncology, UCL EGA Institute for Women’s Health, London W1T 7DN, ² Queen Elizabeth Hospital, Gateshead NE9 6SX, ³ St Bartholomew’s Hospital, London EC1A 7BE, ⁴ Liverpool Women’s Hospital, Liverpool L8 7SS, ⁵ Nottingham City Hospital, Nottingham NG5 1PB, ⁶ St Mary’s Hospital, Manchester M13 9WL, ⁷ Derby City Hospital, Derby DE22 3NE, ⁸ Royal Free Hospital, London NW3 2QG, ⁹ St Mary’s Hospital, Portsmouth PO3 6AD, ¹⁰ St Michael’s Hospital, Bristol BS2 8EG, ¹¹ Belfast City Hospital, Belfast BT9 7AB, ¹² University of Wales College of Medicine, Cardiff CF14 4XN, ¹³ Llandudno Hospital, Llandudno LL30 1LB, ¹⁴ James Cook University Hospital, Middlesbrough TS4 3BW, ¹⁵ London School of Economics, London WC2A 2AE, ¹⁶ Create Health Clinic, London W1G 6AJ, ¹⁷ Brighton and Sussex Medical School, University of Sussex, Brighton BN1 9PX, ¹⁸ Harvard Medical School, Boston, MA 02115, USA, ¹⁹ Medical Research Council Clinical Trials Unit, London NW1 2DA

Correspondence to: U Menon u.menon{at}ucl.ac.uk

Objective To describe the factors that contributed to successfulrecruitment of more than 200 000 women to the UK CollaborativeTrial of Ovarian Cancer Screening, one of the largest ever randomisedcontrolled trials.

Design Descriptive study.

Setting 13 NHS trusts in England, Wales, and Northern Ireland.

Participants Postmenopausal women aged 50-74; exclusion criteriaincluded ovarian malignancy, bilateral oophorectomy, increasedrisk of familial ovarian cancer, active non-ovarian malignancy,and participation in other ovarian cancer screening trials.

Main outcome measures Achievement of target recruitment, acceptancerates of invitation, and recruitment rates.

Results The trial was set up in 13 centres with 27 adjoininglocal health authorities. The coordinating centre team was ledby one of the senior investigators, who was closely involvedin planning and day to day trial management. Of 1 243 282 womeninvited, 23.2% (288 955) replied that they were eligible andwould like to participate. Of those sent appointments, 73.6%(205 090) attended for recruitment. The acceptance rate variedfrom 19% to 33% between trial centres. Measures to ensure targetrecruitment included named coordinating centre staff supportingand monitoring each centre, prompt identification and resolutionof logistic problems, varying the volume of invitations by centre,using local non-attendance rates to determine the size of recruitmentclinics, and organising large ad hoc clinics supported by coordinatingcentre staff. The trial randomised 202 638 women in 4.3 years.

Conclusions Planning and trial management are as important astrial design and require equal attention from senior investigators.Successful recruitment needs constant monitoring by a committedproactive management team that is willing to explore individualsolutions for different centres and use central resources toimprove local recruitment. Automation of trial processes withweb based trial management systems is crucial in large multicentrerandomised controlled trials. Recruitment can be further enhancedby using information videos and group discussions.

Trial registration Current Controlled Trials ISRCTN22488978 [controlled-trials.com] .

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