Hunninghake D B, Darby C A, Probstfield J L
Control Clin Trials. 1987 Dec;8(4 Suppl):6S-30S. doi: 10.1016/0197-2456(87)90004-3.
A literature review was conducted to determine what problems exist in accruing adequate numbers of patients for clinical trials. Accrual rates are often not clearly reported, and most studies report that the time period for accrual was extended. Delays in recruitment have an impact on costs and workload throughout the trial. Other problems with the recruitment outcomes include miscalculations in the number of eligible participants in the total population, variations in yield from different types of recruitment sources, and level of community awareness. Planning for recruitment should be part of the overall trial design. Ideally, recruitment planning should be conducted in harmony between the national and local levels. Local community members should be involved. Data-based management of recruitment is necessary and should include a comprehensive data monitoring system with strong administrative support at both central and local levels. Recruitment goals and provisions for corrective action if recruitment lags should be included. Socioeconomic characteristics and attitudes of patients and physicians should be considered in recruitment efforts because they can affect patient participation during all phases of the study.
进行了一项文献综述，以确定在为临床试验招募足够数量的患者方面存在哪些问题。入组率往往没有得到明确报告，而且大多数研究报告称入组时间段有所延长。招募延迟会对整个试验的成本和工作量产生影响。招募结果的其他问题包括对总人口中符合条件的参与者数量计算错误、不同类型招募来源的产出差异以及社区认知水平。招募规划应成为总体试验设计的一部分。理想情况下，招募规划应在国家和地方层面协调进行。当地社区成员应参与其中。基于数据的招募管理是必要的，应包括一个全面的数据监测系统，并在中央和地方层面都有强有力的行政支持。应纳入招募目标以及如果招募滞后时的纠正措施规定。在招募工作中应考虑患者和医生的社会经济特征及态度，因为它们会影响研究各个阶段的患者参与情况。
