StudioRWE

About / Methodology

This tool provides a structured feasibility assessment for RWE projects. Scoring combines:

• Decision Fit (DF): Whether the business decision can be reliably informed by RWE.
• Answerability (AN): Whether the data allow unbiased estimation of the primary effect.
• Execution Feasibility (EF): Ability to operationalize within time/cost/site constraints.
• Evidence Impact (EI): Anticipated influence of results on stakeholders and decisions.

Scorecard modes set decision thresholds:

• Strict: High bar for category minimums and weighted score (≥4.0 for Go).
• Balanced: Default. Requires DF≥3 and Weighted≥3.75 for Go.
• Practical: Tolerant of minor gaps if all categories ≥3 and Weighted≥3.5.

Use “Use Suggested” to auto-map protocol selections to numeric scores, or switch it off to enter expert judgment manually.

Glossary

• DF — Decision Fit: Alignment of question with what RWE can credibly answer (e.g., label enablement, access, HCP insights).
• AN — Answerability: Ability to estimate effect sizes with available variables, adequate sample, comparator feasibility.
• EF — Execution Feasibility: Practicality of sites, timelines, data capture, and completeness to deliver the study.
• EI — Evidence Impact: Likely effect of findings on payer/HTA, medical, marketing, clinical practice, or internal decisions.
• Suggested Score: Auto-converted from protocol values; a convenience baseline.
• Manual Score: Expert override, 0–5 scale per criterion.
• Weighted Total: Sum(score × weight) / Sum(weights completed).