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One Continuous Evidence Strategy: Ending the RCT vs. Real-World Evidence Divide
Clinical efficacy does not equal access. This session shows how a single, intentionally designed evidence strategy can satisfy both FDA and payer requirements, using perimenopause and menopause research as the working example.
Real-world data is often treated as a post-launch afterthought. Used from the start, it can identify treatable patients who are undercoded in claims data (such as women experiencing vasomotor symptoms), turning one dataset into both a trial recruitment pool and a payer value story grounded in unmet need and cost burden.
Gain clarity on:
- How real-world data can identify and define the right patient populations before a protocol is written, improving recruitment efficiency and quantifying burden at scale
- How to design trials for two audiences: a core RCT layer that addresses FDA endpoints, with pre-specified payer-relevant subgroups built in from day one
- How a pragmatic add-on layer generates the HEOR and coverage-relevant evidence payers require, without compromising regulatory rigor
- Why reliable measurement is the gating factor: if a condition cannot be identified consistently at scale, you cannot recruit efficiently, quantify burden, or demonstrate value
