Good practice standards and inspection for real-world data sources
Trials are inspected to check the data are real and traceable. Do the same for the hospital databases used to make regulatory decisions.
Clinical trial data are governed by Good Clinical Practice and inspected; real-world data sources used in regulatory submissions are not. The proposal is a 'GCP for real-world data': standards for provenance, traceability to source records, curation documentation, fitness-for-purpose assessment and inspection rights, with accreditation of data sources. The FDA's RWE framework and EMA's DARWIN EU data quality framework are starting points.
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
Pages like this
not linked directly; found by shared links- IdeaOne international registry, not one per country, for conditional approvals
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaRequire post-approval evidence in patients over 75 and update labels accordingly
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaEvery patient on an accelerated-approval drug enrolled in a registry until confirmation
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaLinked prescribing and outcome data to find drug interactions with cancer therapy
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaWearable activity data as a validated real-world endpoint
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaNo mCODE, no payment: tie oncology reimbursement to a minimal structured record
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaRequire genetic and target-trial evidence before funding any repurposing phase 3
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaAn automated pipeline emulating trials of every common drug against every cancer
Shares Weak real-world evidence and registries, Real-world evidence.