The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective treatments to patients sooner. [FDA US Food & Drug Administration]
"Bayesian methodologies help address two of the biggest problems of drug development: high costs and long timelines,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Providing clarity around modern statistical methods will help sponsors bring more cures and meaningful treatments to patients faster and more affordably.”
Bayesian approaches use a different framework from traditional statistical approaches. In a Bayesian analysis, data from a study are combined with relevant prior information to form a new distribution that can be used for inference and to draw conclusions about safety and efficacy.
Examples of Bayesian calculations used in various ways in clinical trials can include:
- Determining futility or success earlier in adaptive trials.
- Informing design elements like dose selection in subsequent trials.
- Incorporating information from other sources, such as previous clinical study data, real-world evidence, and external or nonconcurrent controls.
- Facilitating subgroup analyses.
- Supporting primary inference in a trial.
The guidance provides recommendations on the appropriate use of Bayesian methods, with an emphasis on the use of these methods to support primary inference. Bayesian methods may be especially valuable for sponsors targeting rare or pediatric indications, where patient populations are smaller.
More>
All are Welcome- Don't Miss this Convening !!!!!!
10th State of Health of Chicago - 5:00 - 8:00 PM CT
Maggiano's Little Italy - Grand - Chicago
Eight impact leaders discussing hot issues impacting healthcare and public health. This is a biennial event - current emphasis - what issues are impacting communities today and how to solve them. More details and to register here>
###
