ideasIdea
At least a third of pivotal-trial sites in community and rural settings
Most cancer patients are treated outside big academic hospitals, but most trials are run inside them. Requiring a share of sites to be community practices would bring trials to where patients are.
Regulators and public funders would expect registrational trials to open at least 30 percent of sites in community oncology practices and non-metropolitan hospitals, supported by hub-and-spoke oversight from an academic centre (the NCORP model). Sponsors report site mix in the application and diversity plan.
Hypothesis
Trials meeting a community-site share will enrol a population closer to the disease's real-world age, race and rurality distribution, and will not have worse data quality by monitoring metrics.
Rationale
NCORP trials enrol more rural and minority patients than academic-only trials; community practices treat the majority of US cancer patients but host a minority of industry trials.
What would test it
Compare demographic representativeness and query rates between industry trials above and below the community-site threshold, using FDA Drug Trials Snapshots and sponsor data.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
3
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.
- Trials do not represent the people who get cancer · Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.