Tice Debra G, Carroll Kelly A, Bhatt Karishma H, Belknap Steven M, Mai David, Gipson Heather J, West Dennis P
Northwestern University, Institutional Review Board Office, 750 N. Lake Shore Drive, Room 725I, Chicago, IL 60611, USA.
J Clin Med Res. 2013 Jun;5(3):185-93. doi: 10.4021/jocmr1320w. Epub 2013 Apr 23.
The impact of non-accrued clinical research (NACR) represents an important economic burden that is under consideration as the U.S. Department of Health and Human Services looks into reforming the regulations governing IRB review. NACR refers to clinical research projects that fail to enroll subjects. A delineation of the issues surrounding NACR is expected to enhance subject accrual and to minimize occurrence of NACR. The authors assessed demographics, characteristics, and reasons for NACR at an academic medical center, including time trends, funding source, research team (principal investigator, department), IRB resource utilization (IRB level of review, number of required IRB reviews, initial IRB turn-around time, and duration of NACR).
The authors analyzed data from 848 clinical research study closures during 2010 and 2011 to determine proportion, incidence, and characteristics of NACR. Studies with subject enrollment during the same time period were used as a comparative measure.
Data from 704 (83.0%) study closures reported enrollment of 1 or more subjects while 144 (17.0 %) reported NACR (zero enrollment). PI-reported reasons for NACR included: 32 (22.2%) contract or funding issues; 43 (30.0%) insufficient study-dedicated resources; 41 (28.4%) recruitment issues; 17 (11.8%) sponsor-initiated study closure and 11 (7.6%) were "other/reason unreported".
NACR is not uncommon, affecting about one in six clinical research projects in the study population and reported to be more common in some other institutions. The complex and fluid nature of research conduct, non-realistic enrollment goals, and delays in both the approval and/or accrual processes contribute to NACR. Results suggest some simple strategies that investigators and institutions may use to reduce NACR, including careful feasibility assessment, reduction of institutional delays, and prompt initiation of subject accrual for multi-center studies using competitive enrollment. Institutional action to support investigators in the conduct clinical research is also encouraged to reduce likelihood of NACR.
非应计临床研究（NACR）的影响构成了一项重大经济负担，在美国卫生与公众服务部考虑改革机构审查委员会（IRB）审查法规之际，这一问题受到关注。NACR指的是未能招募到受试者的临床研究项目。对围绕NACR的问题进行梳理，有望增加受试者招募数量，并尽量减少NACR的发生。作者评估了一家学术医疗中心NACR的人口统计学特征、特点及原因，包括时间趋势、资金来源、研究团队（首席研究员、科室）、IRB资源利用情况（IRB审查级别、所需IRB审查次数、IRB初始周转时间以及NACR持续时间）。
作者分析了2010年至2011年期间848项临床研究结束的数据，以确定NACR的比例、发生率及特点。将同期有受试者入组的研究作为对照。
704项（83.0%）研究结束的数据报告称有1名或更多受试者入组，而144项（17.0%）报告为NACR（零入组）。首席研究员报告的NACR原因包括：32项（22.2%）合同或资金问题；43项（30.0%）研究专用资源不足；41项（28.4%）招募问题；17项（11.8%）由申办方发起的研究结束，11项（7.6%）为“其他/未报告原因”。
NACR并不罕见，在研究人群中约每六项临床研究项目就有一项受其影响，且在其他一些机构中报告更为常见。研究实施的复杂性和多变性、不切实际的入组目标以及审批和/或招募过程中的延迟导致了NACR。结果表明，研究者和机构可采用一些简单策略来减少NACR，包括仔细进行可行性评估、减少机构延迟，以及对多中心研究采用竞争性招募方式迅速启动受试者招募。还鼓励机构采取行动支持研究者开展临床研究，以降低NACR的可能性。
