Good clinical practice appraisal and its significance in proper conductance of clinical trials, global adoption scenario
Authors: Nikita Paliya
Keywords: Good Clinical Practice (GCP), Clinical Trials, Ethical Guidelines, Informed Consent, Regulatory Compliance, ICH-GCP, Patient Safety, Data Integrity, Trial Phases, Research Ethics.
Abstract:
Good Clinical Practice (GCP) guidelines serve as the cornerstone for ethical and scientifically sound clinical research, providing a globally recognized framework to ensure the safety, rights, and well-being of trial participants while maintaining the credibility of collected data. This review comprehensively examines the historical evolution of GCP, beginning from unethical research practices in the early 20th century to the establishment of internationally harmonized ICH-GCP standards. The article outlines the core principles of GCP, including informed consent, risk-benefit assessment, scientific rigor, and proper documentation, and illustrates how these principles integratively function across all phases of clinical trials—from protocol design to trial closure and post-study reporting. Furthermore, it explores the critical regulatory and legal implications of GCP adherence and how it facilitates ethical oversight, regulatory approvals, and international collaboration. The review also addresses common challenges in GCP implementation, such as variability in compliance across regions, logistical constraints, and knowledge gaps, while highlighting the numerous benefits of compliance, including enhanced data validity, patient trust, global acceptance, and institutional credibility. Ultimately, this article underscores the indispensable role of GCP in upholding the ethical and scientific integrity of clinical trials in an increasingly complex global research environment.
