# Validate real-world progression against central imaging review

Source: https://onco.cc/ideas/idea-data-rwpfs-validation-programme/  
OnCo record `idea-data-rwpfs-validation-programme` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Real-world studies say a drug 'stopped working' based on clinic notes. Check how often that matches a proper scan review, and fix the definitions so the two agree.

## Summary

Real-world PFS (rwPFS) and real-world response are derived from clinician notes and imaging reports, with definitions that differ by vendor. Concordance with RECIST-based central review is only moderately studied. The proposal is a programme in which a sample of real-world progression events in federated datasets is re-read by blinded central radiology, error rates are published by cancer type and data source, and a harmonised definition with known operating characteristics is adopted by regulators.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Harmonised, validated rwPFS definitions will show agreement with RECIST-based progression within one month in more than 80 percent of events for solid tumours and will be accepted as a supportive endpoint in regulatory submissions.
- Rationale: Endpoint validity is the main reason regulators discount RWE for effectiveness; a one-time validation programme is far cheaper than the trials RWE is meant to supplement.
- Proposed test: Re-read 1,500 real-world progression events across three cancers with blinded RECIST review; publish sensitivity, specificity and timing bias by data source.
- Maturity: early-clinical
- Actor: research

## Sources

- Bottleneck evidence (Weak real-world evidence and registries): Gyawali, Hey & Kesselheim, Assessment of the clinical benefit of cancer drugs receiving accelerated approval (JAMA Intern Med 2019): https://doi.org/10.1001/jamainternmed.2019.0462

## Connected records

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/), [Imaging](https://onco.cc/fronts/imaging/)
- companies: [Tempus AI](https://onco.cc/companies/tempus/)
- terms: [Progression-free survival (PFS)](https://onco.cc/terms/pfs/), [Real-world evidence](https://onco.cc/terms/real-world-evidence/), [RECIST](https://onco.cc/terms/recist/)
- bottlenecks: [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)
- key papers: [Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval](https://onco.cc/key-papers/paper-gyawali-jama-intern-med/)

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