Rationale and methods for site selection for a trial using a novel intervention to treat stimulant abuse

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• 作者：Diane Warden^a ; ^{Diane.Warden@UTSouthwestern.edu} ; Madhukar H. Trivedi^a ; Tracy L. Greer^a ; Edward Nunes^b ; Bruce D. Grannemann^a ; Viviana E. Horigian^c ; Eugene Somoza^d ; Kolette Ring^a ; Tiffany Kyle^e ; José ; Szapocznik^c
• 关键词：IRB ; Institutional Review Board ; STRIDE ; Stimulant Reduction Intervention using Dosed Exercise ; CTN ; Clinical Trials Network ; CTP ; Community Treatment Program ; PI ; Principal Investigator
• 刊名：Contemporary Clinical Trials
• 出版年：2012
• 出版时间：January 2012
• 年：2012
• 卷：33
• 期：1
• 页码：29-37
• 全文大小：341 K

文摘

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.