Post by AESARA

When AESARA convened the CFL-SASS Collaborative for RWE, we set out to answer a question the field has been working around for years: what does it actually take for real-world evidence to meet FDA's scientifically appropriate and statistically sound evidence standard—not in theory, but in the rooms where HEOR, Medical, Legal, Regulatory, and Compliance teams have to make a call?   The output is PRIME—Principles for RWE Informed by Multistakeholder Expert Consensus. The first multi-sponsor framework built specifically to operationalize the SASS standard for CFL-pathway communication. More than a dozen sponsoring companies. Two supporting organizations. An expert Delphi panel whose recommendations were reviewed by a former US Commissioner of Food and Drugs.   It doesn't restate FDA guidance. It makes the guidance executable.   At #ISPOR2026, Sissi Pham—Collaborative co-chair—will be on the panel where PRIME is introduced to the field.   📍 Unlocking the Power of Real-World Evidence: The CFL-SASS Expert Consensus Issue Panel · Tuesday, May 19 · 10:30–11:30 AM Session link in the first comment.   If your organization is investing in RWE but still wrestling with how to use it confidently in promotional communication, this is the conversation.   #ISPOR2026 #AESARA #CFL #SASS #PRIME