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Ethics of Adaptive Designs for Randomized Controlled Trials.

Gershom Chongwe1, Joseph Ali2, Dan Kabonge Kaye3

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Adaptive clinical trials may pose complexity challenges to participant autonomy but offer efficiency and benefit. Experts debate if adaptive randomization disrupts clinical equipoise, suggesting further discussion is needed.

Keywords:
RCTsadaptive trialsautonomybeneficenceclinical equipoiserandomized controlled trialsresearch ethics

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Area of Science:

  • Clinical trial methodology
  • Bioethics
  • Epidemiology
  • Biostatistics

Background:

  • Adaptive trial designs are increasingly used in clinical research, including randomized controlled trials (RCTs).
  • This rise has sparked debate regarding the ethical and methodological advantages of adaptive RCTs over traditional fixed RCTs.

Purpose of the Study:

  • To examine expert opinions on how adaptive RCTs impact the ethical character of clinical research compared to fixed RCTs.
  • To understand the perceived ethical and methodological trade-offs of adaptive trial designs.

Main Methods:

  • In-depth interviews were conducted with 17 researchers possessing expertise in bioethics, epidemiology, biostatistics, and medicine.
  • Qualitative data from interviews were analyzed to identify expert perspectives on adaptive trial ethics.

Main Results:

  • Approximately half of the experts believed adaptive trials' complexity could threaten participant autonomy, though this is considered manageable.
  • Most experts cited efficiency and potential participant benefit as primary justifications for adaptive trials.
  • A significant debate exists regarding whether adaptive randomization disrupts clinical equipoise, with differing views on uncertainty and information.

Conclusions:

  • Adaptive trial designs present both ethical challenges and potential benefits, requiring careful consideration.
  • Further dialogue is necessary to enhance understanding and effective utilization of adaptive clinical trial designs.
  • Balancing methodological rigor, ethical considerations, and participant well-being is crucial in adaptive trial implementation.