Site selection in community-based clinical trials for substance use disorders: strategies for effective site selection.

摘要

BACKGROUND: The importance of conducting substance use disorder treatment research in real-world settings is now well recognized. While this approach to clinical trials research offers a variety of benefits, challenges also arise. Selecting high-quality sites to participate is critical to recruitment, retention, and overall trial performance when conducting multi-site, community-based clinical trials of treatments for substance use disorders. OBJECTIVES: Over the past 10 years, the National Institute on Drug Abuse-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN) has strived to conduct high-quality, well-managed clinical trials. This includes developing methods for site selection to be used by investigators conducting CTN trials. METHODS: We review site selection strategies from two community-based multi-site clinical trials conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network. RESULTS: Issues relevant to site selection include the clinical trial design, availability of appropriate clinical population, and organizational attributes of potential clinical research sites. Site selection strategies include reviewing regional epidemiologic data, collecting standard site selection surveys, evaluating clinic data on existing patient populations, and site selection interviews and visits. CONCLUSION: This article describes considerations for selecting research sites and identifies specific strategies to employ when selecting community-based sites for participation in clinical trials.