COVID - What's the FDA's Approach on Pre-Specification?

• 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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