Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer.
Publication/Presentation Date
3-1-2012
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.
Volume
33
Issue
2
First Page
279
Last Page
285
ISSN
1559-2030
Published In/Presented At
Kumar, N., Crocker, T., Smith, T., Pow-Sang, J., Spiess, P. E., Egan, K., Quinn, G., Schell, M., Sebti, S., Kazi, A., Chuang, T., Salup, R., Helal, M., Zagaja, G., Trabulsi, E., McLarty, J., Fazili, T., Williams, C. R., Schreiber, F., Slaton, J., … Anderson, J. K. (2012). Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer. Contemporary clinical trials, 33(2), 279–285. https://doi.org/10.1016/j.cct.2011.11.004
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
22101219
Department(s)
Administration and Leadership
Document Type
Article