Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).
Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).
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DOI：
10.1111/cts.12003
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发表时间：
2013-02
期刊：
影响因子：
--
通讯作者：
Trachtman H
中科院分区：
文献类型：
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作者：
Ferris M;Norwood V;Radeva M;Gassman JJ;Al-Uzri A;Askenazi D;Matoo T;Pinsk M;Sharma A;Smoyer W;Stults J;Vyas S;Weiss R;Gipson D;Kaskel F;Friedman A;Moxey-Mims M;Trachtman H
我们描述局灶节段性肾小球硬化临床试验（FSGS CT）在识别和招募参与者进入研究的经验。这项由美国国立卫生研究院资助的研究是一项多中心、开放标签、随机比较环孢素与口服地塞米松脉冲加霉酚酸酯的研究，在达到入组目标方面遇到了困难和延迟。尽管有患者权益组织的支持和积极的招募策略，这些问题还是发生了。发现了多个障碍，包括：(1)参与中心对潜在事件FSGS患者数量的不准确估计；（二）延误取得某一试验制剂的；(3)从IRB批准到执行分包合同的时间延长（平均7.5±0.8个月）；(4)从IRB批准到受试者入组时间延长（平均19.6±1.4个月）；(5)重组临床协调核心基础设施，使资源与招生相匹配。一项基于网络的匿名调查显示，网站相关的障碍患者招募。各种招募工具的价值在促进患者入组方面具有边际效用。我们的结论是，研究批准和监管启动以及测试有前景的新药的后勤改进是促进肾脏学随机临床试验入组的重要因素。
We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology.