Contemporary Clinical Trials 2012;33(1):29-37. [doi: 10.1016/j.cct.2011.08.011]
Diane Warden, MBA (University of Texas Southwestern Medical Center, TX Node), Madhukar H. Trivedi, MD (University of Texas Southwestern Medical Center, TX Node), Tracy L. Greer, PhD (University of Texas Southwestern Medical Center, TX Node), Edward V. Nunes, MD (New York State Psychiatric Institute, GNY Node), Bruce D. Grannemann, MA (University of Texas Southwestern Medical Center, TX Node), Viviana Horigian, MD (University of Miami, FNA Node), Eugene C. Somoza, MD, PhD (University of Cincinnati/CinARC, OV Node), Kolette M. Ring (University of Texas Southwestern Medical Center, TX Node), Tiffany Kyle, PhD (Center for Drug-Free Living, Inc., FNA Node), José Szapocznik, PhD (University of Miami, FNA Node).
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. This report illustrates how the study specific features and requirements of the Stimulant Reduction Intervention Using Dosed Exercise (STRIDE) protocol (CTN-0037), a multisite clinical trial in the National Drug Abuse Treatment Clinical Trials Network evaluating the efficacy of exercise or health education for stimulant abuse treatment, are linked to firm and flexible site selection criteria. The authors also present an iterative, multi-step approach to site selection including building awareness about the study and screening and evaluating sites using these criteria.
Conclusions: 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. The success of these selection criteria and comprehensive approach to site selection has yet to be determined. However, to fill the gap in the literature about the science of site selection, models and tools based on this and other trialists' experiences are needed. It would be useful to see reports on this issue from other researchers. (Article (Peer-Reviewed), PDF, English, 2012)
Keywords: Community health services | CTN protocol development | CTP participation | Exercise | Research design | Site selection | Stimulant abuse | Contemporary Clinical Trials (journal)
Document No: 767, PMID: 21946515, PMCID: PMC3263926.
Submitted by CTN Dissemination Librarians, 10/12/2011.