---
title: >-
  Use of negative control outcomes to assess the comparability of patients
  initiating lipid-lowering therapies
description: >-
  Explore this publication on real-world evidence: Use of negative control
  outcomes to assess the comparability of patients initiating lipid-lowering
  therapies..
date: '2021-01-01'
author: Sara N. Levintow, Alexander Breskin
category: Publications
tags:
  - University of North Carolina at Chapel Hill
  - Abstract/Manuscript
  - Approval & Commercialization
  - 'Yes'
  - Health System Partner
  - Pharmacoepidemiology & Drug Safety
  - Methods/Pharmacoepi
  - R&D
canonical_url: >-
  https://www.headwaterscience.com/resources/publications/acad-university-of-north-carolina-at-chapel-hill/use-of-negative-control-outcomes-to-assess-the/
source: Headwater Science
license: © 2026 Headwater Science. All rights reserved.
slug: use-of-negative-control-outcomes-to-assess-the
id: 4QCvNSnrNFhjZ4pUs31oP4
contentType: article
---

## Challenge

NCOs had been proposed as tools to assess unmeasured confounding in comparative drug studies, but their real-world performance had not been rigorously validated in a large lipid-lowering therapy cohort using an active comparator new-user design.

## Solution

Target RWE researchers applied NCOs to a real-world comparative analysis of patients initiating lipid-lowering therapies, demonstrating how NCO balance and imbalance can be used to gauge confounding control success before primary outcomes are analyzed.

## Impact

Validating NCO utility in a large active-comparator lipid study demonstrates that Target RWE's NCO-based validity checking can reliably detect confounding structure, providing pharma partners with a credible bias-assessment tool for regulatory submissions.

## Use Cases / Links

NCO validation in lipid-lowering comparative effectiveness for regulatory-grade bias assessment, Active comparator new-user design with NCO as validity check for cardiovascular drug programs