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.
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References
Clinical Trial Regulation (CTReg) EU No. 536/2014. Available via European Commission. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf. Accessed 02 Sept 2019
Clinical Trials Directive (CTDir), Directive 2001/20/EC. Available via European Commission. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf. Accessed 02 Sept 2019
Code of Federal Regulations. Available via Electronic Code of Federal Regulations (e-CFR). https://www.ecfr.gov/cgi-bin/ECFR?page=browse. Accessed 02 Sept 2019
European Commission communication 2010/C 82/01 (CT-1). Available via European Commission. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:082:0001:0019:EN:PDF. Accessed 02 Sept 2019
Sect. 505(d) of the Food, Drug and Cosmetic (FD&C) Act. Available via FDA webpage on FD&C Act Chap. V: Drugs and Devices. https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-v-drugs-and-devices#Part_A. Accessed 02 Sept 2019
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Pernice, M., Colley, A. (2022). Regulatory Requirements in Clinical Trials. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52636-2_51
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DOI: https://doi.org/10.1007/978-3-319-52636-2_51
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