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All Times EDT

Wednesday, September 23
Wed, Sep 23, 11:30 AM - 12:45 PM
Virtual
Using Real-World Data for Regulatory Decision-Making

Key Considerations in Using Real-World Evidence to Support Drug Development (301264)

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*Pingyan Chen, Southern Medical University, China 

Keywords: Real world use, fit-for-purpose

Randomized Controlled Trials (RCTs) remains as the mainstream for generating key evidence to support drug development. Limitations of RCTs include stringent entry criteria reducing the representativeness of the trial population to the target population, the standard trial interventions not being completely consistent with real world clinical practice, and sample size constraints leading insufficient evaluation of certain disease areas such as in rare disease setting. Therefore, how to use real-world evidence (RWE) especially as complementary evidence to RCTs in evaluating the efficacy and safety of drugs, has become a common and challenging question for global regulatory agencies, the pharmaceutical industry and academia. In this presentation, key considerations in using RWE to support drug development will be discussed including defining the role and the scope of application of RWE that is consistent with the stage of the drug development and support better understanding of the totality of the evidence generated from both RCTs and RWEs. Regulatory guidance from various regulatory agencies will be discussed.