Real-World Evidence Methodology

Our Approach

Choosing theright approach requires a clear understanding of the question, the decision context, and the strengths and limitations of available data.

What makes our methodology unique:

Question-first design: we start with the scientific and decision-making question, then identify the most appropriate methods and data
Experience across regulatory and applied settings: methods shaped by decades of work in real-world regulatory and clinical research
Depth in distributed and multi-site research: designing methods that scale across large, complex data environments, including internationally
Experience across therapeutic areas: allowing methods and insights to translate across diverse clinical contexts
Focus on validity and interpretability: prioritizing approaches that produce credible, decision-relevant results

What We Do

We provide epidemiologic leadership and consulting to design studies that arescientifically robust, feasible, and aligned with regulatory, clinical, and policy needs:

Study design and protocol development: selecting appropriate designs for specific research questions
Causal inference and confounding control: including target-trial emulation, propensity score methods, instrumental variable approaches, and self-controlled designs
Use of real-world data sources: guidance on claims, EHR, registry, and linked data
Multi-site and distributed study design: methods for scalable, coordinated analyses
Sequential and rapid surveillance: supporting active surveillance and timely evidence generation
Validation and outcome confirmation: designing approaches to ensure outcome accuracy
Sensitivity and quantitative bias analyses: evaluating assumptions and strengthening inference

Highlighted Publications and Study Protocols

Effectiveness and Safety of the Recombinant Zoster Vaccine in Adult Patients with Systemic Lupus Erythematosus: A Claims-Based Retrospective Cohort Study in the USA

Authors: Mayer SE, Kluberg SA, Spence O, Oraichi D, Seifert H, Ali O, Yun H, Simon AL, Ko JS, Hugh C, Her M, Shattuck K, Jamal-Allial A, Djibo DA, Daniels K, Ma Q, McMahill-Walraven CN, Ogilvie RP, Palmsten K, Selvan M, Ziyadeh N, Ogdie A, George MD

Published in RMD Open on August 7, 2025

Risk of Incident Gout Following Exposure to Recombinant Zoster Vaccine in US Adults Aged ≥50 Years

Authors: Kluberg SA, Simon AL, Alam SM, Peters A, Horgan C, Li D, Moyneur E, Messenger-Jones E, Platt R, McMahill-Walraven CN, Djibo DA, Daniels K, Jamal-Allial A, Pernar CH, Ziyadeh NJ, Ma Q, Selvan M, Spence O, Oraichi D, Seifert H, Franck V, Gamble S, Yun H
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Published in Seminars in Arthritis and Rheumatism on July 14, 2024

Explore Publications

Explore our full publication library to learn more about the studies and methods that inform our work.
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publications