ideasIdea
An open commons of patient-reported outcome data from cancer trials
Pool the side-effect and quality-of-life data patients report in trials into one open database so regimens can be compared honestly and models can be built.
PRO data from trials sit in sponsor archives and are rarely shared or comparable. Project Data Sphere and Vivli show that trial data sharing is feasible. The proposal is a dedicated PRO commons with standardised instruments and formats (PRO-CTCAE, EORTC QLQ-C30, PROMIS), mandatory deposition for publicly funded trials and incentives for industry, and tools for cross-trial comparison of symptom burden by regimen and patient characteristics.
Hypothesis
Within three years the commons contains PRO data from over 100 trials and supports at least ten published cross-regimen tolerability comparisons that inform guidelines and decision aids.
Rationale
Tolerability is only meaningful in comparison, and comparison requires pooled, standardised data. The infrastructure for sharing trial data exists; PROs are simply not prioritised.
What would test it
Seed the commons with data from cooperative-group trials and one industry partner; measure deposition rates, reuse and citations.
Maturity
speculative
Who has to act
data
Cost to try
Medium ($1M to $50M)
Years to first evidence
3
Bottlenecks it attacks
- Toxicity and quality of life are undervalued · Trials measure how long people live, not how they live. Side-effects are under-reported and under-treated.
- Data silos · Records, scans, genomes and outcomes sit in separate systems that cannot talk. Every patient's experience is lost to the next.