52906
document
Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer . 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 .
52907
Intervention_Educational
multi-media and community outreach
52908
Intervention_Other
Screening logs
52909
Participant_Condition
prostate cancer .
52910
Participant_Sex
men
52911
Participant_Condition
prostate cancer
52912
Participant_Sample-size
3547
52913
Participant_Sample-size
n=3092
52914
Participant_Sample-size
216
52915
Participant_Sample-size
n=113
52916
Participant_Sample-size
n=29
52917
Participant_Sample-size
( 94