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Background <p>Accelerated clinical trials for drugs and vaccines during global health crises allow for rapid access but pose research ethics and integrity challenges. Understanding these challenges is crucial for preserving research participants’ safety and supporting research fairness and trustworthiness. This study aims to explore the research ethics and research integrity challenges associated with the acceleration of clinical trials.</p> Methods <p>This qualitative interview study used semi-structured online interviews with key stakeholders in the regulation, design, implementation, and publication of clinical trials as professionals (i.e. trial experts from academia, pharmaceutical companies, non-governmental organizations and national and international regulatory authorities and publishers) recruited using purposive sampling. Interviews were conducted online from April to July of 2023. Transcripts were thematically analysed using deductive and inductive coding through MAXQDA software.</p> Results <p>The main challenges identified were: amplified familiar challenges related to participant recruitment and informed consent; lack of guidance for, and pressure on, ethics and scientific review processes; missing strategies and ambiguous responsibilities in public communication; and poor collaboration, coordination and competition for research resources and supportive structures among research groups Recommendations included: greater engagement with patients throughout the accelerated clinical trial process from design to implementation; providing Research Ethics Committees with specific training on accelerated trials; promoting transparent public communication; fostering international collaboration; and shifting from an industry-centred to a people-centred acceleration.</p> Conclusion <p>These findings highlight the need for systemic changes in the conduct of accelerated clinical trials, including the openness of clinical research and international coordination to address ethical and integrity issues, ensuring scientific rigor and public trust and promoting justice.</p>

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Research ethics and integrity challenges in accelerated clinical trials, an interview study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月26日

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  • Clàudia Pallisé Perelló,
  • Giulia Inguaggiato,
  • Loïs van Eck,
  • Hanna K. de Jong,
  • Sabine M. Hermans,
  • Martin P. Grobusch,
  • Mariëtte van den Hoven,
  • Natalie Evans

摘要

Background

Accelerated clinical trials for drugs and vaccines during global health crises allow for rapid access but pose research ethics and integrity challenges. Understanding these challenges is crucial for preserving research participants’ safety and supporting research fairness and trustworthiness. This study aims to explore the research ethics and research integrity challenges associated with the acceleration of clinical trials.

Methods

This qualitative interview study used semi-structured online interviews with key stakeholders in the regulation, design, implementation, and publication of clinical trials as professionals (i.e. trial experts from academia, pharmaceutical companies, non-governmental organizations and national and international regulatory authorities and publishers) recruited using purposive sampling. Interviews were conducted online from April to July of 2023. Transcripts were thematically analysed using deductive and inductive coding through MAXQDA software.

Results

The main challenges identified were: amplified familiar challenges related to participant recruitment and informed consent; lack of guidance for, and pressure on, ethics and scientific review processes; missing strategies and ambiguous responsibilities in public communication; and poor collaboration, coordination and competition for research resources and supportive structures among research groups Recommendations included: greater engagement with patients throughout the accelerated clinical trial process from design to implementation; providing Research Ethics Committees with specific training on accelerated trials; promoting transparent public communication; fostering international collaboration; and shifting from an industry-centred to a people-centred acceleration.

Conclusion

These findings highlight the need for systemic changes in the conduct of accelerated clinical trials, including the openness of clinical research and international coordination to address ethical and integrity issues, ensuring scientific rigor and public trust and promoting justice.