Recruitment to multicentre trials-lessons from UKCTOCS: descriptive study

Menon, Usha, Gentry-Maharaj, Aleksandra, Ryan, Andy, Sharma, Aarti, Burnell, Matthew, Hallett, Rachel, Lewis, Sara, Lopez, Alberto, Godfrey, Keith, Oram, David, Herod, Jonathan, Williamson, Karin, Seif, Mourad, Scott, Ian, Mould, Tim, Woolas, Robert, Murdoch, John, Dobbs, Stephen, Amso, Nazar, Leeson, Simon, Cruickshank, Derek, McGuire, Ali, Campbell, Stuart, Fallowfield, Lesley J., Skates, Steve, Parmar, Mahesh and Jacobs, Ian (2008) Recruitment to multicentre trials-lessons from UKCTOCS: descriptive study. British Medical Journal, 337. a2079. ISSN 0959-535X

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Abstract

OBJECTIVE: To describe the factors that contributed to successful recruitment of more than 200,000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomised controlled trials. DESIGN: Descriptive study. SETTING: 13 NHS trusts in England, Wales, and Northern Ireland. PARTICIPANTS: Postmenopausal women aged 50-74; exclusion criteria included ovarian malignancy, bilateral oophorectomy, increased risk of familial ovarian cancer, active non-ovarian malignancy, and participation in other ovarian cancer screening trials. MAIN OUTCOME MEASURES: Achievement of target recruitment, acceptance rates of invitation, and recruitment rates. RESULTS: The trial was set up in 13 centres with 27 adjoining local health authorities. The coordinating centre team was led by one of the senior investigators, who was closely involved in planning and day to day trial management. Of 1 243,282 women invited, 23.2% (288 955) replied that they were eligible and would like to participate. Of those sent appointments, 73.6% (205 090) attended for recruitment. The acceptance rate varied from 19% to 33% between trial centres. Measures to ensure target recruitment included named coordinating centre staff supporting and monitoring each centre, prompt identification and resolution of logistic problems, varying the volume of invitations by centre, using local non-attendance rates to determine the size of recruitment clinics, and organising large ad hoc clinics supported by coordinating centre staff. The trial randomised 202,638 women in 4.3 years. CONCLUSIONS: Planning and trial management are as important as trial design and require equal attention from senior investigators. Successful recruitment needs constant monitoring by a committed proactive management team that is willing to explore individual solutions for different centres and use central resources to improve local recruitment. Automation of trial processes with web based trial management systems is crucial in large multicentre randomised controlled trials. Recruitment can be further enhanced by using information videos and group discussions. Trial registration Current Controlled Trials ISRCTN22488978. See also Erratum in: BMJ. 2008;337:a2976.

Item Type: Article
Keywords: UKCTOCS, Ovarian cancer, Randomised Controlled trial, Oncology, Ovarian Cancer
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine > RA0001 Medicine and the state. Including medical statistics, medical economics, provisions for medical care, medical sociology > RA0418 Medicine and society. Social medicine. Medical sociology
R Medicine > RA Public aspects of medicine > RA0418 Medicine and society. Social medicine. Medical sociology

R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
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Depositing User: Tracy Woodcock
Date Deposited: 26 Aug 2011 14:30
Last Modified: 11 Mar 2017 03:24
URI: http://sro.sussex.ac.uk/id/eprint/7132
Google Scholar:24 Citations

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