How to Survive and Succeed in the Design and Execution of a Collaborative Randomized Controlled Trial.

Abstract

This article guides the design and execution of successful collaborative randomized controlled trials (RCTs). Aimed at researchers looking to impact clinical practice, it highlights the advantages of RCTs over observational studies in driving clinical advancements. The article details essential steps in trial development, starting with assembling a core team of a principal investigator, experienced collaborator, methodologist, patient representative, and coordinator. Critical strategies for defining impactful research questions, selecting adequate primary endpoints, and developing a robust protocol are discussed. Additional emphasis is placed on patient-centered outcomes and data integrity, supported by carefully designed electronic case report forms. The article also covers strategies for recruiting collaborators, and managing ethical approvals across multiple centers. Ultimately, it offers insights from the author's experience, encouraging new researchers to overcome challenges in launching their first RCT and reinforcing the role of high-quality, multicentric research in enhancing patient care and clinical outcomes.