Keys to success in clinical trials: A practical review

Clinical research is a highly specialized and rapidly evolving field of expertise. Clinical trial (CT) sites face a continually changing legal and regulatory landscape, making research conduct and program operations challenging. Despite the high number of CTs being conducted, few sources provide a comprehensive summary of key elements essential to the success of clinical trials units (CTUs). Consequently, we set out to provide a practical review on this topic based on collective experience of CT professionals from major academic medical centers. The ultimate result of our group's work is the list of "top 11" essential components of a successful academic CTU implementation. Specific topics discussed in this manuscript include financial and organizational management, new trial feasibility assessment, standardization of procedures, centralization of resources, compliance and safety monitoring, pharmacy support, patient recruitment, effective marketing, institutional support, building (and working with) diverse teams, encouraging clinician engagement, and the importance of continuing professional education. Academic CTUs able to successfully implement key components of the above 11-point program are more likely to perform better in the high-intensity, complex, extensively regulated, and competitive CT environment of today. The following core competencies are addressed in this article: Interpersonal and communication skills, medical knowledge, practice-based learning and improvement, professionalism, systems-based practice.