Negative Control Outcomes in Observational Studies of Effectiveness : ISPOR Webinar
- kenashman
- Jun 12
- 1 min read
Wed 18 June 2025
Real-world data are increasingly being used to supplement traditional randomized clinical trials in the evaluation of medical interventions. The output, or real-world evidence, generated from observational research may be used for decision-making by regulatory authorities, health- technology assessment bodies, clinicians, and other stakeholders.
An important and recognized threat to validity in observational studies of comparative effectiveness or safety results from unmeasured or mismeasured confounders. This presentation will focus on the use of negative control outcomes as a mechanism to evaluate confounding before embarking on a comparative analysis. The application of negative control outcome methods has the potential to strengthen study design, analysis, and interpretation of real-world data and the credibility of the resulting real-world evidence.
Learning Objectives
Selection of negative control outcomes prior to initiating comparative effectiveness or safety research.
Identification of confounding mechanisms in the target patient population.
Interpretation of negative control outcomes effect estimates and the mitigation of uncontrolled confounding in negative control outcome analyses.
Moderator:
Yeshashwini Chenna, MS, Technical Manager, Global Statistical Programming, Amgen, Bothell, Washington, USA
Speakers:
Alan Brookhart, PhD, Professor, Department of Population Health, Duke University, Durham, NC, USA
Zafar Zafari, PhD, Associate Professor, University of Maryland School of Pharmacy, Baltimore, MD, USA
Shia Kent, PhD, Associate Director, Center for Observation Research, Amgen, Los Angeles, CA, USA
