2025/11/05 by Cheryl Grandinetti, Mandy Budwal‐Jagait, Hocine Abid +10
Medicine · Economics, Econometrics and Finance · Mathematics · #Ethics in Clinical Research #Health Systems, Economic Evaluations, Quality of Life #Statistical Methods in Clinical Trials
paper · doi:10.1002/cpt.70120
As clinical trial design and conduct continue to evolve with innovative approaches, new technologies, and emerging data sources, regulatory frameworks are undergoing significant updates to align with these advancements. This article explores recent revisions to the International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP) E6(R3) and the regulatory perspectives on adopting a risk-proportionate approach to trial design and conduct. Drawing from insights shared at the FDA-MHRA-HC 2024 Joint GCP Symposium, this article highlights the key themes shaping the future of clinical trials, including quality-by-design (QbD), risk proportionality, and cross-regulatory collaboration. Additionally, this article addresses the impact of the COVID-19 pandemic in accelerating trial innovations, such as the use of decentralized trial elements and digital health technologies (DHTs), while also emphasizing the need for regulatory flexibility to accelerate their adoption. Regulatory agencies, such as the US-FDA, MHRA-UK, and Health Canada, have issued guidance to promote clinical trial flexibilities and proportionate, risk-based approaches, ensuring the protection of participant rights, safety, and well-being and overall reliability of trial results. These updates advocate for proportionate approaches to trial oversight, which allow for innovation while safeguarding the trial's critical to quality factors. As regulators continue to refine their practices and enhance collaboration, the integration of QbD and risk proportionality into clinical trials and cross-regulatory collaboration will ultimately drive more efficient, participant-centered trials and improve the global clinical research landscape.