Impact Story: A Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks
FDA CDER statisticians are designing trials with adaptive features to make clinical evaluation of new drug treatments more efficient and informative.
A new study from the FDA is showing how Bayesian statistics can be applied to a clinical trial in real-time.
The gist is this - how can we perform a randomized trial without engaging in an unethical practice of withholding potentially lifesaving treatments from "control" patients?
Their solution - set the "standard of care" as a moving target where promising treatments become standard more quickly and are immediately tested against.
Could this approach be expanded beyond medical emergencies and applied to oncology treatments with significant unmet needs and lacking standard of care options?
bit.ly/Bayesiantrial
https://www.fda.gov/Drugs/ScienceResearch/ucm616374.htm
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