Negative Control Outcomes in Observational Studies of Effectiveness

June 18, 2025

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Title: Negative Control Outcomes in Observational Studies of Effectiveness  

Wednesday, June 18, 2025
10:00AM EDT | 2:00PM UTC | 4:00PM CEST

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Description

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. 

Speakers:

Alan Brookhart, PhD, Professor, Department of Population Health, Duke University, North Carolina, USA

Yeshashwini Chenna, MS, Technical Manager, Global Statistical Programming, Amgen, Bothell, Washington, USA

Zafar Zafari, PhD, Associate Professor, University of Maryland School of Pharmacy, Baltimore, Maryland, USA


Brought to you by:  ISPOR Statistical Methods in HEOR Special Interest Group


Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.

Reservations are on a first-come, first-served basis.

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