Abstract:
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Real world data (RWD) in concert with randomized trials add to an integrated evidence generation system throughout the drug life cycle. This presentation will focus on how real world evidence (RWE) can inform phase 2/3 trial design and its key role in adaptive pathways and accelerated approval. Regulators explicitly look for RWE to contribute to incremental evidence development as soon as medications are marketed via accelerated approval pathways. The presentation speaks about RWE that is fit for decision making, i.e. is meaningful evidence, valid evidence, expedited evidence, and transparent evidence. The presentation covers methodological aspects as well as database considerations.
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