Real-world evidence is only as strong as the methodology behind it.
Evidence, not vibes. Strategy, not decks. Every study I design starts with a clear question and a protocol built to survive scrutiny.
The Evidence Hierarchy
Click any level to explore — with opinionated notes from a practitioner
Data Sources — With Opinions
Administrative Claims
“Imperfect, but if you understand what it captures and misses, incredibly powerful. The backbone of most RWE studies.”
Electronic Health Records
“Rich clinical detail, messy data engineering. NLP is unlocking what structured fields can’t capture.”
Patient Registries
“Purpose-built for research, limited by enrollment bias. Strongest for rare diseases and longitudinal follow-up.”
Patient-Reported Outcomes
“The patient’s voice. Often underutilized in RWE. Combining PRO with claims data is the future.”
Linked Datasets
“The holy grail: claims + EHR + genomics + PRO. Hard to do, transformative when done right.”
Wearables & Digital Biomarkers
“The newest frontier. Continuous, objective measurement. Still figuring out analytical frameworks.”
Methodologies That Move the Needle
Causal Inference in Observational Data
The bar for RWE isn't just statistical significance. It's causal clarity.
- •Target trial emulation for regulatory-grade designs
- •Instrumental variables to find natural experiments
- •Difference-in-differences for policy evaluations
Synthetic Control Arms
Historical patient data plus AI algorithms can simulate control group outcomes.
- •Cuts trial costs and timelines significantly
- •Essential for rare diseases with small populations
- •Avoids ethical issues of withholding treatment
Federated Learning for Multi-Site Evidence
Models train locally at each institution and share only analytical outputs, not patient data.
- •Privacy-preserving multi-center studies
- •HIPAA/GDPR compliant by design
- •Enables collaboration without data movement
References
- Yahoo Finance. Real-world data (RWD) market global report 2026: market to grow from $1.88 billion in 2025 to $2.15 billion in 2026 at a CAGR of 14.54%. Published 2026. Accessed February 2026. finance.yahoo.com
- Cozen O'Connor. FDA's guidance on the use of real-world evidence for medical devices. Published 2026. Accessed February 2026. cozen.com
- Li J, et al. Real-world evidence supporting FDA label expansions, 2022-2024. Drug Saf. 2024. Accessed February 2026. pubmed.ncbi.nlm.nih.gov
- US Food and Drug Administration. FDA eliminates major barrier to using real-world evidence. FDA Press Release. December 2025. Accessed February 2026. fda.gov
- Merative. Real-world data trends 2026: the shift to quality and AI precision. Published 2026. Accessed February 2026. merative.com
Let's Talk Evidence
Need a partner for RWE strategy, study design, or evidence generation? I'd welcome the conversation.