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Asian Journal of Ethics in Health and Medicine

2023 Volume 3

Ethical and Integrity Challenges in Accelerated Clinical Trials: Perspectives from Key Stakeholders


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  1. Department of Ethics, Law and Humanities, Amsterdam Public Health Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, 1081HV, The Netherlands.
  2. Department of Infectious Diseases, Centre for Tropical Medicine and Travel Medicine, Amsterdam Public Health – Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.
  3. Department of Global Health, Amsterdam Institute for Global Health and Development, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
Abstract

During major global health emergencies, speeding up clinical trials for new drugs and vaccines helps deliver solutions more quickly, yet it also creates notable difficulties in research ethics and scientific integrity. It is essential to identify and address these difficulties to safeguard the well-being of those participating in studies and uphold fairness and credibility in scientific work. The current study examines the specific research ethics and integrity issues that arise when clinical trials are conducted at an accelerated pace. A qualitative approach was adopted, relying on semi-structured interviews conducted remotely with individuals who play central roles in overseeing, planning, carrying out, and disseminating clinical trials. These interviewees were seasoned professionals drawn from academic settings, pharmaceutical firms, non-governmental bodies, and national and international regulatory agencies and publishing outlets. They were chosen via purposive sampling techniques. The interviews were conducted online from April to July 2023. Resulting transcripts underwent thematic analysis that combined deductive and inductive coding strategies, supported by the MAXQDA software package. Key challenges that surfaced were: heightened forms of longstanding issues involving the enrolment of participants and the process of obtaining informed consent; inadequate direction coupled with heavy demands placed on ethical and scientific evaluation procedures; the absence of well-defined approaches and unclear accountability when communicating with the wider public; and weak levels of teamwork, insufficient coordination, plus fierce rivalry over research funding and necessary support systems among different research teams. Among the proposed measures were: involving patients more actively at every stage of the accelerated trial pathway, beginning with planning and extending through execution; equipping Research Ethics Committees with specialized preparation focused on fast-tracked studies; advancing clear and open dialogue aimed at the general public; building stronger cross-border partnerships; and transitioning from acceleration models driven primarily by commercial interests to ones that place people at the center. The outcomes emphasize the need for broad-ranging reforms in how accelerated clinical trials are managed. These reforms need to encompass enhanced transparency within clinical research activities and better global-level coordination. Such steps would help address concerns about ethics and integrity, while maintaining high standards of scientific quality, preserving public confidence, and supporting equitable outcomes.


How to cite this article
Vancouver
Perelló CP, Inguaggiato G, Hoven MVD, Evans N, Eck LV, Jong HKD, et al. Ethical and Integrity Challenges in Accelerated Clinical Trials: Perspectives from Key Stakeholders. Asian J Ethics Health Med. 2023;3:324-38. https://doi.org/10.51847/TlWaw8GG8A
APA
Perelló, C. P., Inguaggiato, G., Hoven, M. V. D., Evans, N., Eck, L. V., Jong, H. K. D., Hermans, S. M., & Grobusch, M. P. (2023). Ethical and Integrity Challenges in Accelerated Clinical Trials: Perspectives from Key Stakeholders. Asian Journal of Ethics in Health and Medicine, 3, 324-338. https://doi.org/10.51847/TlWaw8GG8A

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