Overcoming Challenges in Multisite Trials.

BACKGROUND: Conducting multisite studies has many challenges, including determining the geographic distance between sites, ensuring effective communication, monitoring intervention and data integrity, handling institutional policy variations, seeking institutional review board approval with unique site needs or complex subcontracts, and planning for additional costs. OBJECTIVES: This article discusses common challenges in conducting multisite studies and identifies strategies to overcome these challenges using real-world examples from the literature, the authors' research studies, and their personal experiences. METHODS: A summary of articles on multisite trials conducted within the past 10 years was explored to uncover common challenges in conducting multisite trials. To enrich the context, exemplars from authors' works are included. Based on literature and experience, strategies to combat challenges are summarized. RESULTS: Unique issues related to multisite studies include site selection, use of epicenters/coordinating centers, hiring/managing staff, fidelity monitoring, institutional review board approval, statistical considerations, and approaches to authorship. CONCLUSION: Addressing challenges a priori can improve scientific rigor, reproducibility, and evidence from multisite studies. Given the benefits to scientific rigor, reproducibility, and design, findings from multisite studies are more likely to provide evidence to transform clinical practice and influence policy.