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.