Data Management & Biostatistics

The Ethical Challenges of Adaptive Design

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

The webinar will examine particular design adaptations and discuss 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 Thomas Laage, Director of Product Development Consulting, consider examples from published and unpublished Adaptive Design clinical trials, some successful and not so successful.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.

Watch this webinar today and hear these experts consider the importance of careful design, meticulous planning, and rigorous ethical review in adaptive design clinical studies.

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.