title: Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study.
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.
  
  
  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.
authors.affiliation: Gynaecological Oncology, UCL EGA Institute for Women's Health, London W1T 7DN. u.menon@ucl.ac.uk
authors.forename: Usha
authors.initials: U
authors.lastname: Menon
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Gentry-Maharaj
authors.forename: Andy
authors.initials: A
authors.lastname: Ryan
authors.forename: Aarti
authors.initials: A
authors.lastname: Sharma
authors.forename: Matthew
authors.initials: M
authors.lastname: Burnell
authors.forename: Rachel
authors.initials: R
authors.lastname: Hallett
authors.forename: Sara
authors.initials: S
authors.lastname: Lewis
authors.forename: Alberto
authors.initials: A
authors.lastname: Lopez
authors.forename: Keith
authors.initials: K
authors.lastname: Godfrey
authors.forename: David
authors.initials: D
authors.lastname: Oram
authors.forename: Jonathan
authors.initials: J
authors.lastname: Herod
authors.forename: Karin
authors.initials: K
authors.lastname: Williamson
authors.forename: Mourad
authors.initials: M
authors.lastname: Seif
authors.forename: Ian
authors.initials: I
authors.lastname: Scott
authors.forename: Tim
authors.initials: T
authors.lastname: Mould
authors.forename: Robert
authors.initials: R
authors.lastname: Woolas
authors.forename: John
authors.initials: J
authors.lastname: Murdoch
authors.forename: Stephen
authors.initials: S
authors.lastname: Dobbs
authors.forename: Nazar
authors.initials: N
authors.lastname: Amso
authors.forename: Simon
authors.initials: S
authors.lastname: Leeson
authors.forename: Derek
authors.initials: D
authors.lastname: Cruickshank
authors.forename: Ali
authors.initials: A
authors.lastname: McGuire
authors.forename: Stuart
authors.initials: S
authors.lastname: Campbell
authors.forename: Lesley
authors.initials: L
authors.lastname: Fallowfield
authors.forename: Steve
authors.initials: S
authors.lastname: Skates
authors.forename: Mahesh
authors.initials: M
authors.lastname: Parmar
authors.forename: Ian
authors.initials: I
authors.lastname: Jacobs
mesh_terms: 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