Department of Epidemiology, H. Lee Moffitt Cancer Center & Research Institute at University of South Florida College of Medicine, Tampa, FL 33612, USA.
Contemp Clin Trials. 2012 Mar;33(2):279-85. doi: 10.1016/j.cct.2011.11.004. Epub 2011 Nov 11.
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.
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.
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.
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.
本报告旨在描述针对前列腺癌高危男性的多中心、二期化学预防试验的持续招募策略、成功经验、挑战和解决方案。
我们在具有支持性基础设施的机构中开发并实施了一项多中心临床试验，由一支经验丰富且投入的医生和临床试验工作人员组成的招募团队领导，实施多媒体和社区外展策略，以实现招募目标。审查筛选记录以确定影响入组的趋势以及与患者、方案和基础设施相关的障碍，并对方案进行修订。
2008 年 1 月至 2011 年 2 月期间，共有 3547 人进行了预筛选，其中 94%（n=3092）因诊断为癌症或良性活检结果而被认为不合格。在这些人中，有 216 人被认为有资格进一步筛选，其中 52%（n=113）因患者相关因素拒绝参与，14%（n=29）因方案相关排除标准而被淘汰。94 人同意参与，其中 34%（n=74）符合所有入选标准，随机分配接受研究药物或安慰剂。在所有研究地点，该临床试验的受试者招募有 99%是通过医生招募和推荐完成的，只有不到 1%的受试者通过其他招募策略入组。
需要采取现代的受试者招募方法和频繁的评估，以确保能够应对入组方面出现的挑战以及不断发展的科学文献。重点投资改善医生招募系统可能是实现化学预防试验招募目标的关键。
