Making the Case for Negative Control Outcome Studies in a Real-World Evidence Setting.

Challenge

NCO studies are methodologically valuable for detecting unmeasured confounding, but the practical case for including them as a required component of a real-world evidence generation workflow had not been formally articulated for regulatory audiences.

Solution

Target RWE researchers presented an oral lecture synthesizing the scientific rationale, practical implementation steps, and regulatory value proposition for NCO studies as a standard gating mechanism in RWE programs.