Rita M. Kristy, MS
Senior Director, Medical Affairs Statistics
Astellas Pharma Global Development,
Northbrook, IL, USA

David J. Vanness, PhD
Associate Professor, Population Health Sciences
School of Medicine and Public Health, University of Wisconsin-Madison
Madison, WI, USA

To provide statistical leadership for strengthening the use of appropriate statistical methodology in health economics and outcomes research and improve the analytic techniques used in real world data analysis.

  • To review and recommend statistical methods used in outcomes research studies
  • To provide insight on the impact of using appropriate statistical methodology in a rigorous manner to enhance credible research
  • To better understand the limitations of analyses and methods used by the HEOR community

Statistics are used in many outcomes research studies, in which understanding the proper use of the methods and approaches that have been developed around certain types of analyses is crucial to producing reliable and valid results that may be reproducible to the rest of the research community. Appropriate application of statistics is the foundation of credible research.

To answer a number of research questions, there are various statistical methods used in real world data analysis such as multiplicity, Bayesian analyses, estimation in disease state changes, model averaging, machine learning/artificial intelligence, and causal inferences, to name a few. However, there are large gaps in the statistical knowledge base as it relates to real world data analysis including the effect of missing values in claims databases, their impact on analyses, and appropriate methods for imputation.

Working Groups:
  • Key Project
    Missing Data in Health Economics and Outcomes Research

    Co-Chairs of Key Project:

    Necdet Gunsoy, PhD, MPH, Manager of Analytics and Innovation for Value Evidence and Outcomes at GlaxoSmithKline (GSK), England, United Kingdom
    Gianluca Baio, PhD, MSc, Reader in Statistics and Health Economics, University College London (UCL), England, United Kingdom

  • Member Engagement

    Webinars (coming soon)

    • Estimating Treatment Effects Using Observational Data

    • Longitudinal Data Analysis for Health Economics and Outcomes Research


Handling Missing Values in Real-World Data: Are There Challenges for Regulatory Decisions for Medical Products?
May 2018 – ISPOR 2018, Forum Presentation, Baltimore, MD, USA

Pragmatic Clinical Trials to Estimate Treatment Effects: Are They Worth the Effort?
November 2017 – ISPOR 20th Annual European Congress, Issue Panel Presentation, Glasgow, Scotland, UK


Group Leadership Members
  Working Documents

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