Five real-world evidence project designs
Illustrative project scopes for pharmaceutical and medical device teams.
Comparative effectiveness
How do outcomes differ after starting treatment A versus treatment B? Use an active-comparator, new-user cohort from claims or EHR data. Deliver a cohort flow, balance diagnostics and adjusted absolute risks with uncertainty.
Post-market safety and device performance
How often do complications, revisions or adverse outcomes occur after use? Link device registries or identifiable device records to follow-up data where feasible. Deliver event rates, follow-up completeness and sensitivity analyses for outcome definitions.
Treatment patterns and care pathways
What do patients receive first, and when do they switch, stop or escalate? Use longitudinal claims or EHR records. Deliver a treatment sequence diagram, time-to-switch estimates and the rules used to define treatment lines.
Disease burden and healthcare utilization
What is the burden of care, and which groups account for the most utilization? Use claims, EHR or registry data as available. Deliver subgroup estimates for admissions, visits and costs with denominators and follow-up windows.
External comparator feasibility
Can routine-care data support a credible comparison for a single-arm trial? Map trial eligibility, time zero, endpoints and follow-up to candidate datasets. Deliver a feasibility matrix and an assessment of comparability before estimating an effect.
Explore the comparative effectiveness demo
FDA examples of real-world evidence use