---
title: >-
  Making the Case for Negative Control Outcome Studies in a Real-World Evidence
  Setting.
description: >-
  Explore this publication on real-world evidence: Making the Case for Negative
  Control Outcome Studies in a Real-World Evidence Setting..
date: '2024-01-01'
category: Publications
tags:
  - David Pritchard
  - Approval & Commercialization
  - 'Yes'
  - Oral Presentation
  - R&D
canonical_url: >-
  https://www.headwaterscience.com/resources/publications/author-david-pritchard/making-the-case-for-negative-control-outcome-studies-in-a/
source: Headwater
license: © 2026 Headwater. All rights reserved.
slug: making-the-case-for-negative-control-outcome-studies-in-a
id: 2DcTxXbbN6uniycID2AsRx
contentType: article
---

## 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.