title: Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer.
abstract: OBJECTIVE
  The goal of this report is to describe the on going strategies, successes, challenges and solutions for recruitment in this multi-center, phase II chemoprevention trial targeting men at high risk for prostate cancer.
  
  
  METHODS
  We developed and implemented a multi-center clinical trial in institutions with supportive infrastructure, lead by a recruitment team of experienced and committed physicians and clinical trial staff, implementing multi-media and community outreach strategies to meet recruitment goals. Screening logs were reviewed to identify trends as well as patient, protocol and infrastructure -related barriers impacting accrual and revisions to protocol implemented.
  
  
  RESULTS
  Between January 2008 and February 2011 a total of 3547 individuals were prescreened with 94% (n=3092) determined to be ineligible based on diagnosis of cancer or benign biopsy results. Of these, 216 were considered eligible for further screening with 52% (n=113) declining to participate due to patient related factors and 14% (n=29) eliminated due to protocol-related criteria for exclusion. Ninety-four (94) subjects consented to participate with 34% of these subjects (n=74) meeting all eligibility criteria to be randomized to receive study agent or placebo. Across all sites, 99% of the recruitment of subjects in this clinical trial is via physician recruitment and referral with less than 1% responding to other recruitment strategies.
  
  
  CONCLUSIONS
  A contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials.
authors.affiliation: Department of Epidemiology, H. Lee Moffitt Cancer Center & Research Institute at University of South Florida College of Medicine, Tampa, FL 33612, USA. nagi.kumar@moffitt.org
authors.forename: Nagi
authors.initials: N
authors.lastname: Kumar
authors.forename: Theresa
authors.initials: T
authors.lastname: Crocker
authors.forename: Tiffany
authors.initials: T
authors.lastname: Smith
authors.forename: Julio
authors.initials: J
authors.lastname: Pow-Sang
authors.forename: Philippe E
authors.initials: PE
authors.lastname: Spiess
authors.forename: Kathleen
authors.initials: K
authors.lastname: Egan
authors.forename: Gwen
authors.initials: G
authors.lastname: Quinn
authors.forename: Michael
authors.initials: M
authors.lastname: Schell
authors.forename: Said
authors.initials: S
authors.lastname: Sebti
authors.forename: Aslam
authors.initials: A
authors.lastname: Kazi
authors.forename: Tian
authors.initials: T
authors.lastname: Chuang
authors.forename: Raoul
authors.initials: R
authors.lastname: Salup
authors.forename: Mohamed
authors.initials: M
authors.lastname: Helal
authors.forename: Gregory
authors.initials: G
authors.lastname: Zagaja
authors.forename: Edouard
authors.initials: E
authors.lastname: Trabulsi
authors.forename: Jerry
authors.initials: J
authors.lastname: McLarty
authors.forename: Tajammul
authors.initials: T
authors.lastname: Fazili
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Williams
authors.forename: Fred
authors.initials: F
authors.lastname: Schreiber
authors.forename: Joel
authors.initials: J
authors.lastname: Slaton
authors.forename: J Kyle
authors.initials: JK
authors.lastname: Anderson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001706:Biopsy; D018890:Chemoprevention / Q000379:methods*; D003937:Diagnosis, Differential; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000473:pathology / Q000517:prevention & control*; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents
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