ideasIdea
Publish why patients were screened out of each trial
Trials record why each screened patient did not join, but that data is never shared. Publishing it would show which rules block the most people and which are pointless.
Sponsors report, per trial, the number screened, the number enrolled and screen-failure reasons in a standard coded vocabulary (specific criterion, patient declined, logistics) to the trial registry at completion. Aggregate analysis identifies criteria that exclude many patients across trials with no safety justification and informs eligibility reform.
Hypothesis
Public screen-failure reporting will identify a small set of criteria responsible for the majority of exclusions in each disease and lead to their removal in subsequent protocols, increasing eligible fractions.
Rationale
Eligibility reform currently relies on simulations against real-world data; actual screen-failure data is the ground truth and already collected on screening logs. Making it visible creates pressure to fix the worst criteria.
What would test it
A registry pilots a screen-failure data field for oncology trials; after two years, analyse which criteria dominate and whether protocols from participating sponsors changed.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks
- Trials enrol too few, too slowly · Fewer than one in ten adults with cancer joins a trial. Trials close for lack of patients, not lack of ideas.
- 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.