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PERSPECTIVE article

Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1507021
This article is part of the Research Topic Regulatory Science and Meta Science as Components of Regulation of Medical Products and Practices View all 6 articles

Gaps in the Ethical Governance of Pharmaceutical Clinical Trials in Europe

Provisionally accepted
Rosemarie de la Cruz Bernabe Rosemarie de la Cruz Bernabe 1,2*Shereen Cox Shereen Cox 1Christine Gispen-de Wied Christine Gispen-de Wied 2,3
  • 1 Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway
  • 2 Faculty of Health and Social Sciences, University of South-Eastern Norway (USN), Kongsberg, Vestfold, Norway
  • 3 Gispen4RegulatoryScience Consultancy, Bilthoven, Netherlands

The final, formatted version of the article will be published soon.

    The ethical governance of pharmaceutical clinical trials in Europe, particularly under Regulation 536/2014, is intended to ensure the safety, rights, and well-being of participants. Despite this regulatory framework, significant gaps in ethical oversight remain. This paper identifies five key deficiencies: (1) European regulations only partially address ethical imperatives set by international guidelines, thereby restricting the ethical mandate of relevant entities; (2) the role of research ethics committees is largely limited to pre-approval activities, reducing continuous oversight during trials; (3) GCP inspectors operate within a narrow scope regarding ethical oversight, which limits their ability to identify a broad range of unethical practices; (4) there is insu icient transparency and collaboration between RECs and regulators, specifically GCP inspectorates, leading to fragmented oversight; and (5) there is minimal integration of ethical findings into the marketing authorization decision process by entities such as clinical assessors and the CHMP. To bridge these gaps, the paper suggests a shift from a prospective ethics review to a comprehensive end-to-end model of ethical governance.

    Keywords: ethical governance, clinical trials, research ethics committees, GCP inspections, end-to-end ethics, clinical trial oversight, European Medicines Agency

    Received: 06 Oct 2024; Accepted: 06 Dec 2024.

    Copyright: © 2024 Bernabe, Cox and Gispen-de Wied. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Rosemarie de la Cruz Bernabe, Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.