ideasIdea
Mandatory public reporting of vein-to-vein time and failure rate per CAR-T product
Patients and doctors cannot see how long each CAR-T maker takes or how often manufacturing fails. Publishing this would create pressure to get faster and more reliable.
Vein-to-vein times for commercial CAR-T range from roughly three to eight weeks and out-of-specification rates from a few percent to over ten, but these figures appear only in trial publications and investor slides. The proposal is a regulatory condition that each approved cell therapy reports, quarterly and publicly, median and 90th percentile apheresis-to-infusion time, out-of-specification and manufacturing failure rates, and the proportion of enrolled patients never infused, stratified by country.
Hypothesis
Public benchmarking is followed by a fall in median vein-to-vein time of at least a week across the market within two years and convergence of failure rates towards the best performer.
Rationale
Public reporting of hospital outcomes and airline punctuality changed behaviour where private reporting did not. Manufacturers already collect these data for their own control; publication is cheap.
What would test it
Begin with voluntary reporting through a registry such as CIBMTR or EBMT, publish two years of data, and evaluate whether times and failure rates changed relative to the prior period.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
- 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.