Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer

Nagi Kumar, Theresa Crocker, Tiffany Smith, Julio Pow-Sang, Philippe E. Spiess, Kathleen Egan, Gwen Quinn, Michael Schell, Said Sebti, Aslam Kazi, Tian Chuang, Raoul Salup, Mohamed Helal, Gregory Zagaja, Edouard Trabulsi, Jerry McLarty, Tajammul Fazili, Christopher R. Williams, Fred Schreiber, Joel SlatonJ. Kyle Anderson

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)279-285
Number of pages7
JournalContemporary Clinical Trials
Volume33
Issue number2
DOIs
StatePublished - Mar 2012

Bibliographical note

Funding Information:
The research study was funded by the National Institute of Health-National Cancer Institute R01 CA12060-01A1 .

Keywords

  • Chemoprevention trials
  • Clinical trials
  • Green tea polyphenols
  • Prostate cancer
  • Recruitment
  • Screening
  • Trial accrual

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