Abstract
Background: Many biomedical researchers and stakeholders may be unfamiliar with clinical trial concepts, designs, and factors affecting data integrity. Complexities are further increased in multinational trials. This article is intended to summarize the clinical trial process, with emphasis on the planning and design of multinational trials. The goal is to provide insight and guidance to the international research community.
Clinical trial guidelines have been generated by reviewing textbooks, published articles, regulatory guidelines, and the authors’ personal experience. The workflow reported here summarizes the literature to produce a practical template in order to guide the planning and design of multinational clinical trials. This template can be broadly useful during the planning and design steps of a nascent clinical trial. However, in-depth knowledge of each individual process of a clinical trial is essential. One is encouraged to use this template as a guide for early drafts of a clinical trial.
Conclusion: Detailed research for the template components can further enhance the knowledge of biomedical research structures, improve the quality of clinical trials, and ultimately enhance the published results.
Keywords: Multinational clinical trial, multiregional clinical trial, clinical trial guidelines, clinical trial processes, clinical trial planning, clinical trial design.
Graphical Abstract
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