ideasIdea
Map trial case report forms to the registry standard so trial and routine data join
Trials and hospital records describe the same things in different languages. Publish the translation so trial patients can be followed for life in routine data and trial results compared with routine care.
Clinical trial data follow CDISC standards; routine data follow mCODE or OMOP. Formal, maintained mappings (CDISC to mCODE, CDISC to OMOP) would allow trial participants to be followed via registries after the trial ends, trial cohorts to be compared with matched real-world cohorts, and completed trial datasets to be pooled with routine data. CDISC and HL7 have a joint project; the proposal funds it to completion and requires sponsors to deliver the mapped dataset alongside submissions.
Hypothesis
Mapped trial datasets will enable long-term follow-up of more than 80 percent of participants via registries at less than a tenth of the cost of active follow-up, and permit trial-versus-real-world comparisons for every new approval within a year.
Rationale
Long-term follow-up is the most expensive part of many trials and the reason late toxicities and late relapses are under-documented; registries already hold the information.
What would test it
Map three completed phase 3 datasets to mCODE, link to a national registry, and compare registry-derived survival with trial-recorded survival; measure agreement and cost.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
3
Bottlenecks it attacks
- Data silos · Records, scans, genomes and outcomes sit in separate systems that cannot talk. Every patient's experience is lost to the next.
- 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.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.