Regulatory Requirements in Clinical Trials

Michelle Pernice () and Alan Colley ()
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Michelle Pernice: Dynavax Technologies Corporation
Alan Colley: Amgen, Ltd

Chapter 24 in Principles and Practice of Clinical Trials, 2022, pp 459-478 from Springer

Abstract: Abstract Understanding the regulatory requirements for initiating and conducting clinical trials is a crucial starting point and success factor in any plan to advance drug development in humans. Regulatory requirements go beyond what is considered compliance with good clinical practice (GCP) and other standards. Regulations provide the guardrails and opportunities for safe, efficient, and purposeful drug development. While regulations provide the groundwork of what is to be considered “right” and “wrong” in drug development, there is a level of uncertainty that is intentionally left for sponsor interpretation in order to provide flexibility. Further, regulators usually represent the views of the country or region within their specific purview, a structure which lends itself to dissonance between different regulations/guidelines, furthering the need for sponsor interpretation. Such interpretation is conveyed in the finished clinical trial application (CTA) or investigational new drug (IND) application and then subject to the regulators’ review and approval. As important as it is to understand the written requirements, it’s equally important to understand how and when to engage with the regulators to expedite drug development. If done well, the combination of understanding the regulations, implementing sponsor interpretation, and utilizing opportunities for engagement with regulatory agencies can lead to ultimately deliver useful treatments to patients. In this chapter, global, regional, and national clinical trial regulatory considerations will be described to enable the reader to understand the principles and practice of conceptualizing, submitting, initiating, and completing clinical trials in the regulated environment of drug development.

Keywords: Regulatory; FDA; EMA; Marketing authorization; BLA/NDA; MAA; IND; CTA; Approval; Sponsor (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_51

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