Clinical Research: Phase 1 - Phase 4

Ethical Considerations in Adaptive Design Clinical Trials

What happens when a widely recognized advance in clinical trial design poses ethical questions? Find out in Premier Research’s webinar, Ethical Considerations in Adaptive Design Clinical Trials.

The hour-long event examines particular design adaptations and discusses the ethical obstacles they present — and potentially resolve. Jennifer Nezzer, Director of Biostatistics, and Dr. Thomas Laage, Director of Product Development Consulting, consider examples from published and unpublished Adaptive Design clinical trials, some successful and not so successful. Among the observations they discuss:

  • Analysis of interim results, designed to protect a trial’s scientific basis, can withhold from patients information necessary to make informed judgments.
  • The complexity of AD trials can amplify the challenges of therapeutic misconception, creating inferential problems that must be balanced against benefits.
  • Successful use of AD can lead to more efficient allocation of societal resources for research in both the public and commercial realms.