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Michael Harhay, PhD, MPH Image

Dr. Harhay, founding director of the Center for Clinical Trials Innovation, specializes in the statistical design, analysis, and interpretation of randomized trials and cohort studies. He has been involved in more than 30 randomized trials and has particular research interests in (composite) outcome measure development and interpretation, complex trial designs (e.g., Bayesian, cluster-randomized, and multi-arm), missing data methods, and applications of artificial intelligence and machine learning in clinical research. His co-authored review of Bayesian statistics for clinical research in The Lancet has become a widely used reference in the field. His interests also extend to forensic epidemiology and the application of Bayesian reasoning and causal inference to questions of causation in legal and regulatory contexts.

At Penn, he oversees a broad extramurally-funded research portfolio, including supporting more than two dozen grants as a co-investigator, and serving as a Principal Investigator of the following NIH awards:

  1. NHLBI R01 developing Bayesian causal inference methods for ARDS trials (R01-HL168202).
  2. NIA R01 hybrid type I pragmatic cluster trial to improve hospital palliative care delivery (R01-AG082874).
  3. Penn’s NHLBI/NIGMS ARDS, Pneumonia, and Sepsis (APS) Phenotyping Consortium site (U01-HL168419).
  4. NICHD R01 Bayesian phase II trial of a high- versus low-ΔP ventilation strategy (25 vs. 15 cmH2O) in children (R01-HD117422).

Dr. Harhay has authored more than 300 scientific publications and is active across a wide range of international research activities, including scientific society and trial steering and monitoring committees, multi-national research consortia, and as deputy editor of the American Journal of Respiratory and Critical Care Medicine and as an editor of the International Journal of Epidemiology.

Penn Appointments & Affiliations

  • Deputy Director, Division of Epidemiology

External Appointments & Affiliations

  • Deputy Editor, American Journal of Respiratory and Critical Care Medicine
  • Steering Committee Member and Chair of the Data Science Subcommittee, NHLBI/NIGMS ARDS, Pneumonia, and Sepsis (APS) Phenotyping Consortium
  • Honorary Research Fellow, Institute of Clinical Trials and Methodology, University College London
  • Scientific Advisory Board, MiNK Theraputics
  • Scientific Advisory Board, Intensive Care Platform Trial (INCEPT) 

Awards

  • 2025 Jo Rae Wright Award for Outstanding Science, American Thoracic Society
  • 2024 Marjorie A. Bowman New Investigator Award in Health Evaluation, University of Pennsylvania
  • 2023 Early Career Epidemiologist Award, American College of Epidemiology
  • 2021 Early Career Achievement Award, Assembly on Critical Care, American Thoracic Society

Research Highlights

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