title: Rationale and methods for site selection for a trial using a novel intervention to treat stimulant abuse.
abstract: 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.
authors.affiliation: Department of Psychiatry, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., Dallas, TX 75390-9119, USA. Diane.Warden@UTSouthwestern.edu
authors.forename: Diane
authors.initials: D
authors.lastname: Warden
authors.forename: Madhukar H
authors.initials: MH
authors.lastname: Trivedi
authors.forename: Tracy L
authors.initials: TL
authors.lastname: Greer
authors.forename: Edward
authors.initials: E
authors.lastname: Nunes
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Grannemann
authors.forename: Viviana E
authors.initials: VE
authors.lastname: Horigian
authors.forename: Eugene
authors.initials: E
authors.lastname: Somoza
authors.forename: Kolette
authors.initials: K
authors.lastname: Ring
authors.forename: Tiffany
authors.initials: T
authors.lastname: Kyle
authors.forename: José
authors.initials: J
authors.lastname: Szapocznik
mesh_terms: D000697:Central Nervous System Stimulants / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000379:methods*; D005081:Exercise Therapy / Q000379:methods*; D006266:Health Education / Q000379:methods*; D006801:Humans; D018579:Patient Selection; D019966:Substance-Related Disorders / Q000628:therapy*
chemical_list: D000697:Central Nervous System Stimulants