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Published on: August 4, 2023
Design a Clinical Research Protocol: Influence of Real-World Setting
Jonathan Cimino1,2, Claude Braun1,2
1Clinical Research Unit, Fondation Hôpitaux Robert Schuman, 44 Rue d'Anvers, 1130 Luxembourg, Luxembourg.
Abstract:
The design of a clinical research protocol to evaluate new therapies, devices, patient quality of life, and medical practices from scratch is probably one of the greatest challenges for the majority of novice researchers. This is especially true since a high-quality methodology is required to achieve success and effectiveness in academic and hospital research centers. This review discusses the concrete steps and necessary guidelines needed to create and structure a research protocol. Along with the methodology, some administrative challenges (ethics, regulatory and people-management barriers) and possible time-saving recommendations (standardized procedures, collaborative training, and centralization) are discussed.
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