Real-World Evidence Methodology

Real-world evidence studies often involve complex design, data, and analytic challenges.

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

We provide epidemiologic leadership and consulting across the spectrum of real-world evidence generation by collaborating with sponsors to design studies that are scientifically robust, feasible, and aligned with regulatory, clinical, and policy needs. Our experience spans diverse therapeutic areas.

What Makes Our Approach Distinct

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 expertise and consulting to support:

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

We are often engaged when

Study questions are complex or high-stakes
Data sources have important limitations or require careful interpretation
Multiple design options are possible and trade offs must be evaluated
Regulatory or external scrutiny is anticipated
A clear, defensible analytic strategy is needed

Highlighted Publications

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

Published in Seminars in Arthritis and Rheumatism on July 14, 2024

We bring the scientific expertise needed to design real-world evidence studies that are not only feasible—but scientifically sound and decision-ready.

Explore our research