WHIS 2026

One Continuous Evidence Strategy: Ending the RCT vs. Real-World Evidence Divide

October 14, 2026
4:20–5:00 p.m. ET

Therapeutics, Diagnostics & Med Device Innovation 

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
   

Speakers

Kristina Rosa Bolling
Senior Director, Lifecycle Research Strategy - Bayer

Julia Coleman
Associate Research Director, Patient Center Research - Carelon Research

Dr. Mallika Mundkur
Former Deputy Chief Medical Officer - U.S. Food and Drug Administration

Hiangkiat (Jason) Tan
Senior Scientist, HEOR, Life Sciences Research - Carelon Research