Addressing RWE Challenges in Real-Time: The 'Clean Room Committee' Approach

Regulatory guidance for RWE increasingly demands transparency and protection against investigator bias, but no real-time implementation case study had demonstrated how a clean room committee approach could function in practice in a live study.

Target RWE researchers presented a case study of the Clean Room Committee approach applied to a preoperative cefazolin safety study, demonstrating how blinded committee review at pre-specified checkpoints addressed unexpected data challenges without introducing investigator bias.

Demonstrating the CRC approach in a real regulatory study case provides pharma partners and FDA reviewers with a concrete operational model for bias-resistant RWE.

Clean room committee case study for bias-resistant RWE in regulatory submissions, Operational model for investigator bias protection in FDA-facing observational pharmacoepidemiology studies