BERD BITES Learning Series: Adaptive Design in Clinical Trials: Benefits, Challenges and Key Considerations

Monday, January 27, 2025
12:00 pm - 1:00 pm
via Zoom
Registration required »

 

An adaptive design is a clinical trial design that allows for prospectively planned modifications based on accumulating data from the trial.  

An adaptive design has captured significant attention in the clinical trial community. When executed correctly, an adaptive design gives an opportunity to learn from the trial, it may save time, resources and money, and may enhance patient protection or improve decision-making at milestones during product development.

However, it also introduces several challenges related to trial implementation and analysis. Many times, an adaptive design is more difficult to plan, thus takes more time and cost more money in the designing stage than a classical design without adaptive feature. It also presents operational challenges to set up firewalls to ensure that access to unblinded data is restricted. Biases in estimates need to be corrected. Heterogeneity before and after adaptive feature could also be of concern. Therefore, when designing a trial, it is essential to carefully assess the feasibility and true benefits of using an adaptive design.  

In this presentation, we will explore adaptive design, examining its benefits, limitations, and unique considerations.

 

Photo of an Asian woman with shoulder-length wavy hair. She's sitting in a chair with hands folded in her lap. She's wearing a cream-colored blazer and navy flowerful dress, and smiling at the camera.

Presented by Xiting “Cindy” Yang, Ph.D. 

Dr. Cindy Yang is a Statistical Subject Matter Expert at Biomedical Advanced Research & Development Authority (BARDA) under U.S. Department of Health and Human Services (HHS). She has about 20 years clinical trial experience, in both regulatory and industry settings, including 15 years in the FDA. Her statistical expertise includes both frequentist and Bayesian methods. Other interests include adaptive designs and propensity score analysis. She is Associate Editor of Biostatistics & Epidemiology and 2018 Chair of Medical Devices and Diagnostics (MDD) Section of American Statistical Association (ASA). She has a Ph.D. on statistics from Carnegie Mellon University.

 

 

 

Note: BERD Consultations will be available to audience members after the presentation.

BERD Provides: 

  • Consultations on study design for clinical trials, community-based participatory research, and population-based (epidemiologic) studies
  • Protocol review
  • Referrals
  • Quantitative data analysis for CCTS pilots

The BERD Team includes: 

  • Richard Kryscio, PhD (Director)
  • Douglas Zhang, PhD (Co-Director)
  • Reuben Adatorwovor, PhD
  • Emily Slade, PhD
  • Kelsey Karnik, PhD
  • Phil Westgate, PhD
  • Meredith Duncan, PhD
  • Maggie Lang
  • Sarah Jane Robbins

Questions? Contact April Bridenbecker
CCTS Program Coordinator
at adbr245@uky.edu

Social Media