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

Abstract

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.