TY - JOUR
T1 - Recruitment to multicentre trials - Lessons from UKCTOCS: Descriptive study
AU - Menon, Usha
AU - Gentry-Maharaj, Aleksandra
AU - Ryan, Andy
AU - Sharma, Aarti
AU - Burnell, Matthew
AU - Hallett, Rachel
AU - Lewis, Sara
AU - Lopez, Alberto
AU - Godfrey, Keith
AU - Oram, David
AU - Herod, Jonathan
AU - Williamson, Karin
AU - Seif, Mourad
AU - Scott, Ian
AU - Mould, Tim
AU - Woolas, Robert
AU - Murdoch, John
AU - Dobbs, Stephen
AU - Amso, Nazar
AU - Leeson, Simon
AU - Cruickshank, Derek
AU - McGuire, Ali
AU - Campbell, Stuart
AU - Fallowfield, Lesley
AU - Skates, Steve
AU - Parmar, Mahesh
AU - Jacobs, Ian
N1 - CA083639, NCI NIH HHS, United StatesCA086381, NCI NIH HHS, United States, Cancer Research UK, United Kingdom, Department of Health, United Kingdom, Medical Research Council, United Kingdom
PY - 2008/11/29
Y1 - 2008/11/29
N2 - 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.
AB - 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.
U2 - 10.1136/bmj.a2079
DO - 10.1136/bmj.a2079
M3 - Article
C2 - 19008269
SN - 0959-535X
VL - 337
SP - 1283
EP - 1286
JO - Bmj
JF - Bmj
IS - 7681
ER -
