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


METHODS
Descriptive study.


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


METHODS
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.


METHODS
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.
Menon
Usha
U
Gynaecological Oncology, UCL EGA Institute for Women's Health, London W1T 7DN. u.menon@ucl.ac.uk
Gentry-Maharaj
Aleksandra
A
Ryan
Andy
A
Sharma
Aarti
A
Burnell
Matthew
M
Hallett
Rachel
R
Lewis
Sara
S
Lopez
Alberto
A
Godfrey
Keith
K
Oram
David
D
Herod
Jonathan
J
Williamson
Karin
K
Seif
Mourad
M
Scott
Ian
I
Mould
Tim
T
Woolas
Robert
R
Murdoch
John
J
Dobbs
Stephen
S
Amso
Nazar
N
Leeson
Simon
S
Cruickshank
Derek
D
McGuire
Ali
A
Campbell
Stuart
S
Fallowfield
Lesley
L
Skates
Steve
S
Parmar
Mahesh
M
Jacobs
Ian
I
D000368:Aged; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000401:mortality*; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods*; D010051:Ovarian Neoplasms / Q000401:mortality / Q000517:prevention & control*; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D006113:United Kingdom