Retrospective observational RWD feasibility is not one-size-fits-all—and deeper is not always better.
Secondary data may appear fit for purpose until study-critical assumptions are tested. Our new whitepaper presents a modular approach: choose feasibility activities to resolve decision-relevant uncertainty, then use the findings to refine study design.
Highlights:
- Five activities: Metadata review, source interrogation, aggregate checks, patient-level assessment and targeted validation
- Right-sized effort: Test deeper only when unresolved uncertainty could change the study or investment decision
- Feasibility informs design: Refine eligibility, endpoints, follow-up, covariate strategy and analyses—not just source selection
- Decision-ready recommendations: Define source capabilities, key limitations, remaining uncertainty and actionable next steps
This paper focuses on effectiveness, safety, epidemiology and HEOR studies, including HTA and regulatory contexts.
Read the paper to calibrate feasibility to the decision at hand.
Read our whitepaper
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