The Prevalence and Economic Impact of Low-Enrolling Clinical Studies at an Academic Medical Center
The Prevalence and Economic Impact of Low-Enrolling Clinical Studies at an Academic Medical Center
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DOI：
10.1097/acm.0b013e3182306440
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发表时间：
2011-11-01
影响因子：
7.4
通讯作者：
Orwoll, Eric S.
中科院分区：
文献类型：
--
作者：
Kitterman, Darlene R.;Cheng, Steven K.;Orwoll, Eric S.
目的作者评估了单个学术医疗中心低入组临床研究的普遍性和相关的经济影响。方法作者检查了俄勒冈健康与科学大学 (OHSU) 2006 财年至 2009 财年接受机构审查委员会 (IRB) 审查的所有临床研究的招募表现，并按 IRB 审查类型（全委员会、豁免、快速）、资助机制和学术进行了分析。 单元。低入组研究包括那些在研究终止时只有零名或一名参与者的研究。作者计算了 2009 财年与 IRB 审查、财务设置、合同谈判和部门研究启动活动相关的成本，以及低入组研究对 OHSU 的总体经济影响。 结果 在研究期间，共有 837 项临床研究被终止，其中 260 项 (31.1%) 为低入组研究。低入学率研究中政府资助的比例高于行业资助的比例 (P = .006)。作者发现，不同学术单位的低入学率研究比例存在显着差异（从 10% 到 67%）。保守估计，2009 财年低入组研究的无补偿经济影响接近 100 万美元。 结论 相当一部分临床研究产生了高昂的机构和部门费用，但几乎没有带来科学效益。尽管任何研究组织都可能会出现一定比例的低入组研究，但必须对此类研究的总数进行管理，以降低进行研究的总成本并最大限度地增加研究机会。需要采取有效、主动的干预措施来解决低入学率的普遍性和影响。
PurposeThe authors assessed the prevalence and associated economic impact of low-enrolling clinical studies at a single academic medical center.MethodThe authors examined all clinical studies receiving institutional review board (IRB) review between FY2006 and FY2009 at Oregon Health & Science University (OHSU) for recruitment performance and analyzed them by type of IRB review (full-board, exempt, expedited), funding mechanism, and academic unit. A low-enrolling study included those with zero or one participant at the time of study termination. The authors calculated the costs associated with IRB review, financial setup, contract negotiation, and department study start-up activities and the total economic impact on OHSU of low-enrolling studies for FY2009.ResultsA total of 837 clinical studies were terminated during the study period, 260 (31.1%) of which were low-enrolling. A greater proportion of low-enrolling studies were government funded than industry funded (P = .006). The authors found significant differences among the various academic units with respect to percentages of low-enrolling studies (from 10% to 67%). The uncompensated economic impact of low-enrolling studies was conservatively estimated to be nearly $ 1 million for FY2009.ConclusionsA substantial proportion of clinical studies incurred high institutional and departmental expense but resulted in little scientific benefit. Although a certain percentage of low-enrolling studies can be expected in any research organization, the overall number of such studies must be managed to reduce the aggregate costs of conducting research and to maximize research opportunities. Effective, proactive interventions are needed to address the prevalence and impact of low enrollment.