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Contemp Clin Trials. 2012 Mar;33(2):279-85. doi: 10.1016/j.cct.2011.11.004. Epub 2011 Nov 11.

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

Author information

1
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

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.

PMID:
22101219
PMCID:
PMC3268882
DOI:
10.1016/j.cct.2011.11.004
[Indexed for MEDLINE]
Free PMC Article

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