---
title: 'Addressing RWE Challenges in Real-Time: The ''Clean Room Committee'' Approach'
description: >-
  Explore this publication on real-world evidence: Addressing RWE Challenges in
  Real-Time: The ‘Clean Room Committee’ Approach..
date: '2024-01-01'
author: Kathleen Hurwitz, M. Alan Brookhart, PhD, Nuvan Rathnayaka
category: Publications
tags:
  - ISPOR Annual Conference
  - University of North Carolina at Chapel Hill
  - Poster Presentation
  - Approval & Commercialization
  - 'Yes'
  - Health System Partner
  - Methods/Pharmacoepi
  - R&D
canonical_url: >-
  https://www.headwaterscience.com/resources/publications/pub-ispor-annual-conference/addressing-rwe-challenges-in-real-time-the-clean-room/
source: Headwater Science
license: © 2026 Headwater Science. All rights reserved.
slug: addressing-rwe-challenges-in-real-time-the-clean-room
id: 3V7q50VgQAIm8vPMhlrmlY
contentType: article
---

## Challenge

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.

## Solution

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.

## Impact

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.

## Use Cases / Links

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