ideasIdea
Stop excluding people with a prior cancer, controlled HIV, or treated hepatitis
Having had another cancer years ago, or living with well-controlled HIV or hepatitis, still keeps many people out of trials for no good scientific reason. Removing these blanket bans would widen access, especially in communities where these conditions are more common.
Protocols would replace blanket exclusions with condition-specific rules: prior malignancy allowed unless it is likely to interfere with the endpoint; HIV allowed if on effective antiretrovirals with adequate CD4 count; hepatitis B and C allowed if suppressed or cured. The FDA issued a guidance to this effect in 2020; adoption is incomplete and monitoring of adoption is absent.
Hypothesis
Trials adopting these criteria will increase enrolment of Black and Hispanic participants in the US and of participants in high-HIV-prevalence countries, with no detectable difference in efficacy estimates or serious adverse events among the newly eligible.
Rationale
Cancer survivors are a growing population and often have the same disease biology; HIV on modern therapy does not alter most drug pharmacology or checkpoint-inhibitor safety in observational series; hepatitis exclusion is largely a legacy of hepatotoxicity concerns that can be handled by monitoring.
What would test it
Audit new industry phase 3 protocols each year for these exclusions, publish a scorecard, and compare outcomes of the newly eligible subgroup in trials that include them.
Maturity
early clinical
Who has to act
industry
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.
- 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.