Evolution of clinical trials: a comprehensive analysis of ICH E6(R3) and integrated quality management systems in the pharmaceutical industry

M. M. Kamkha; B. Y. Margaeva; N. A. Babicheva; S. E. Ulyanova

doi:10.33380/2305-2066-2026-15-2-2191

Evolution of clinical trials: a comprehensive analysis of ICH E6(R3) and integrated quality management systems in the pharmaceutical industry

M. M. Kamkha, B. Y. Margaeva, N. A. Babicheva, S. E. Ulyanova

https://doi.org/10.33380/2305-2066-2026-15-2-2191

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Abstract

Introduction. In the context of digital transformation and global harmonization of regulatory requirements, the implementation of integrated quality management systems in clinical trials based on ICH E6(R3) has become increasingly relevant.

Aim. To conduct a comparative analysis of ICH E6(R3) against international standards (ISO, GAMP 5, PMBOK/APM-BOK) and assess their adaptability within the Russian regulatory environment.

Materials and methods. A systematic analysis was performed of the Russian regulatory framework – including Federal Law No. 61-FZ of April 12, 2010; Decision No. 79 of the Eurasian Economic Commission Council of November 3, 2016, approving the Good Clinical Practice Rules of the Eurasian Economic Union; and GOST R 52379-2005 "Good Clinical Practice" – as well as international guidelines (ICH, ISO, EMA, PMI, ISPE) and scientific publications from 2020 to 2025 indexed in Scopus and Web of Science.

Results and discussion. It was established that ICH E6(R3) necessitates a shift from reactive oversight to proactive quality management through the integration of risk-based approaches, digital technologies, and interdisciplinary standards. Within the Russian context, gaps in regulatory provisions and insufficient integration of quality management systems were identified.

Conclusion. To align with ICH E6(R3), Russian regulatory authorities and organizations must modernize internal processes, implement Risk-Based Quality Management (RBQM), and harmonize national requirements with international standards.

Keywords

clinical trials, ICH E6(R3), PMBOK/APM-BOK, GAMP 5, ISO, quality, risk, project management

About the Authors

M. M. Kamkha

Lomonosov Moscow State University
Russian Federation

1, Leninskie Gory, Moscow, 119991

B. Y. Margaeva

Lomonosov Moscow State University
Russian Federation

1, Leninskie Gory, Moscow, 119991

N. A. Babicheva

Lomonosov Moscow State University
Russian Federation

1, Leninskie Gory, Moscow, 119991

S. E. Ulyanova

Lomonosov Moscow State University
Russian Federation

1, Leninskie Gory, Moscow, 119991

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For citations:

Kamkha M.M., Margaeva B.Y., Babicheva N.A., Ulyanova S.E. Evolution of clinical trials: a comprehensive analysis of ICH E6(R3) and integrated quality management systems in the pharmaceutical industry. Drug development & registration. 2026;15(2):112-124. (In Russ.) https://doi.org/10.33380/2305-2066-2026-15-2-2191

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