- In a presentation at a workshop at the National Academies of Sciences, Engineering and Medicine, FDA Center for Drug Evaluation and Research's Janet Woodcock said the current clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data.
- She mentioned master protocols (studies that assess multiple therapies in a single disease or a single treatment in multiple diseases) and the development of clinical trial networks as "the future."
- Real-world evidence (RWE) may also play a much larger role since both the 21st Century Cures Act and new user fee laws expand the agency's use of RWE in certain cases. RWE has been used very little historically in the approval process, but represents a big incentive for industry to prove effectiveness, cautioning that it is much more difficult for RWE to uncover small effects since "so many biases are introduced." One opportunity may be using some RWE with randomization.
- Draft guidance on RWE and a new framework on its use should be released by the FDA before 2021.
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