Abstract
Clinical trials are conducted for many reasons, including to determine whether a new drug is safe and effective for a therapeutic use. A clinical study protocol acts as a how-to guide for the conduct of a study and is essential for successful trial execution. When drugs or biologics are being developed for regulatory approval, the Food and Drug Administration (FDA) requires that a clinical protocol be submitted for each planned clinical study or trial enrolling participants in the United States. According to the US Code of Federal Regulations (21 CFR Part 312), the specific elements and level of detail for a protocol can vary depending on the phase of the study. The clinical study protocol for a phase 1 study should be designed with a focus on safety and dosing; protocols for phase 2 and 3 studies should include detailed descriptions for all aspects of the study, including safety, efficacy, and statistical considerations. The US Code of Federal Regulations (21 CFR Part 312) describes specific elements that should be included in all clinical protocols, regardless of the clinical phase. The International Conference on Harmonization Good Clinical Practice Guidelines (ICH GCP E6, Section 6) specify additional sections that should generally be included in a protocol. The objective of this chapter is to describe the elements that should be included in a clinical trial protocol.
The opinions expressed herein are those of the authors and do not necessarily reflect those of the US Food and Drug Administration.
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Kambhampati, R., Mistry, K. (2023). Elements of Clinical Trial Protocol Design. In: Jagadeesh, G., Balakumar, P., Senatore, F. (eds) The Quintessence of Basic and Clinical Research and Scientific Publishing. Springer, Singapore. https://doi.org/10.1007/978-981-99-1284-1_22
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DOI: https://doi.org/10.1007/978-981-99-1284-1_22
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