Department of Psychiatry, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., Dallas, TX 75390-9119, USA.
Contemp Clin Trials. 2012 Jan;33(1):29-37. doi: 10.1016/j.cct.2011.08.011. Epub 2011 Sep 17.
Although the selection of appropriate clinical sites has a significant impact on the successful conduct of clinical trials, no generally accepted model is available for site selection. Use of an appropriate site selection process is even more pertinent when conducting large scale, practical clinical trials in practice settings. This report provides a rationale for selecting sites by identifying both a set of basic site selection criteria important to most trials as well as criteria specific to the features of a particular study's design. In this two-tier system, although all these criteria must be met, some criteria are firm and viewed as essential for a site to conduct the trial. Other criteria, such as those that support study recruitment or participant retention, are flexible. These flexible criteria may be addressed through several alternative solutions that meet the original intent of the criterion. We illustrate how the study specific features and requirements of Stimulant Reduction Intervention using Dosed Exercise (STRIDE), a multisite clinical trial evaluating the efficacy of exercise or health education, added to treatment as usual for stimulant abuse are linked to firm and flexible site selection criteria. We also present an iterative, multi-step approach to site selection including building awareness about the study and screening and evaluating sites using these criteria. This simple model could maximize the chance that selected sites will implement a study successfully and achieve trial aims. It may be helpful to researchers who are developing criteria and methods for site selection for specific clinical trials.
尽管选择合适的临床研究基地对临床试验的成功开展有重要影响，但目前还没有一个被普遍认可的基地选择模型。当在实际环境中进行大规模的实用临床试验时，使用适当的基地选择过程更为重要。本报告通过确定一套对大多数试验都很重要的基本基地选择标准以及特定于特定研究设计特征的标准，为基地选择提供了一个合理的依据。在这个两级系统中，虽然必须满足所有这些标准，但有些标准是硬性的，被视为基地进行试验的必要条件。其他标准，如支持研究招募或参与者保留的标准，则是灵活的。这些灵活的标准可以通过几种满足标准原始意图的替代解决方案来解决。我们举例说明了兴奋剂减少干预使用定量运动（STRIDE）的研究特定特征和要求，该多中心临床试验评估了运动或健康教育作为兴奋剂滥用的常规治疗的疗效，这些特征和要求与硬性和软性的基地选择标准相联系。我们还提出了一种迭代的、多步骤的基地选择方法，包括提高对研究的认识，以及使用这些标准对基地进行筛选和评估。这种简单的模式可以最大限度地提高选定基地成功实施研究并实现试验目标的机会。它可能对正在为特定临床试验制定基地选择标准和方法的研究人员有帮助。
