Episode 251
RWE and the FDA (Part 2)
Interview with Josephine Wolfram
The Effective Statistician - in association with PSI
October 4, 202224m 44s
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Show Notes
Interview with Josephine Wolfram
- RWES are collected through statisticians actually getting involved in the collection of data through interview, survey, and feedback questionnaire from both physicians and patients.
- Validation of data should be accomplished through focusing on the accuracy of the representation of the data from actual settings and how they could be applied in real-life cases.
- Statistical reliability is critical to the value of clinical trials and how they could be applied in actual life situations and health cases.
- Proving to FDA that RWEs are valid enough to provide the support needed by targeted patients is critical to determining the real value that every clinical trial serve.
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