Good Clinical Practice in Clinical Trials: Global Ethics, Regulation, Implementation and Emerging Directions

Good Clinical Practice (GCP) constitutes the internationally accepted ethical and scientific framework governing the design, conduct, monitoring, and reporting of clinical trials involving human participants. It provides safeguards for the rights, safety, and welfare of research participants while ensuring the integrity and credibility of the data generated. The development of GCP has been shaped by historical milestones, ethical deliberations, and regulatory harmonization across jurisdictions. For this review, evidence was sourced from PubMed, Scopus, and Google Scholar covering the period 1947–2023, with a focus on international and national guidelines, regulatory documents, and peer-reviewed literature relevant to biomedical and dental research. The review highlights its application in both biomedical and dental trials, including challenges unique to dental research such as small sample sizes, high dropout rates, and variability in outcome measures. Furthermore, it synthesizes insights from the literature on challenges and critiques associated with implementation, including issues highlighted during the COVID-19 pandemic, the emergence of digital and decentralized trials, artificial intelligence in monitoring, and the need for inclusivity in trial populations. In conclusion, GCP remains an essential framework for ethically sound and scientifically credible clinical research, and dental researchers in particular should apply these principles rigorously to strengthen trial quality and ensure translation into safe and effective patient care.