Evolving Landscape of Good Clinical Practice in Clinical Trials: Challenges and Future Perspectives

Good Clinical Practice (GCP) serves as the ethical and scientific foundation for conducting clinical trials involving human participants. Over the last decade, clinical research has undergone remarkable transformation due to globalization, technological advancement, decentralized trial models, and evolving regulatory expectations. Modern clinical trials increasingly rely on digital technologies, electronic data systems, artificial intelligence, and remote patient monitoring, creating both opportunities and challenges for researchers and regulatory authorities. Key concerns include increasing protocol complexity, participant safety, informed consent in digital environments, data integrity, cybersecurity, and harmonisation of international regulations. Recent updates in International Council for Harmonisation (ICH) guidelines, particularly ICH E6(R3), emphasize risk-based quality management and patient-centered approaches to clinical research. This review discusses the current challenges in implementing GCP, recent regulatory developments, and future perspectives shaping contemporary clinical trials. Understanding these evolving trends is essential for ensuring ethical conduct, regulatory compliance, and high-quality clinical research.

Good Clinical Practice; Clinical Trials; Research Ethics; Regulatory Affairs; ICH-GCP; Patient Safety; Informed Consent; Clinical Research; Regulatory Compliance; Digital Clinical Trials

1. International Council for Harmonisation. ICH Harmonised Guideline for Good Clinical Practice E6(R2). 2016. [Google Scholar] [Crossref]

2. Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4(1): e5. [Google Scholar] [Crossref]

3. Umscheid CA, Margolis DJ, Grossman CE. Key concepts of clinical trials. Clin Transl Sci. 2011;4(5):367–371. [Google Scholar] [Crossref]

4. International Council for Harmonisation. ICH E6(R3) Draft Guideline for Good Clinical Practice. 2023. [Google Scholar] [Crossref]

5. World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. 2013. [Google Scholar] [Crossref]

6. Getz KA, Campo RA. Trial complexity and clinical research performance. Am J Ther. 2017;24(6): e679–e685. [Google Scholar] [Crossref]

7. U.S. Food and Drug Administration. Risk-Based Monitoring Guidance for Industry. 2019. [Google Scholar] [Crossref]

8. Getz KA. Protocol complexity and clinical trial execution challenges. Drug Inf J. 2015;49(4):451–457. [Google Scholar] [Crossref]

9. Kadam RA. Informed consent process: A step further towards making it meaningful. Perspect Clin Res. 2017;8(3):107–112. [Google Scholar] [Crossref]

10. Grady C, et al. Broad consent for research with biological samples. N Engl J Med. 2015; 372:195–197. [Google Scholar] [Crossref]

11. U.S. Food and Drug Administration. Data Integrity and Compliance with CGMP Guidance for Industry. 2018. [Google Scholar] [Crossref]

12. Singh JA, et al. Ethics review of multicenter clinical trials: Challenges and opportunities. Clin Investig. 2019;9(2):45–52. [Google Scholar] [Crossref]

13. Izmailova ES, Ellis R, Benko C. Remote monitoring in clinical trials during the COVID-19 pandemic. Clin Transl Sci. 2020;13(5):838–841. [Google Scholar] [Crossref]

14. TransCelerate BioPharma Inc. Risk-Based Monitoring Methodology. 2017. [Google Scholar] [Crossref]

15. Crocker JC, et al. Patient and public involvement in clinical trial design and conduct. BMJ. 2018;363: k4738. [Google Scholar] [Crossref]

16. Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng. 2018; 2:719–731. [Google Scholar] [Crossref]

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