{"entity":{"id":"idea-tr1-prior-cancer-hiv-hepatitis-inclusion","kind":"idea","name":"Stop excluding people with a prior cancer, controlled HIV, or treated hepatitis","aka":[],"tldr":"Having had another cancer years ago, or living with controlled HIV or treated hepatitis, still keeps patients out of trials for no scientific reason. Condition-specific rules, as FDA guidance recommended in 2020, would replace blanket bans and widen access in communities where these conditions are more common.","summary":"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.","asOf":"2026-09-08","links":[{"label":"FDA: Eligibility Criteria: Patients with HIV, Hepatitis B or Hepatitis C","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-hiv-hepatitis-b-virus-or-hepatitis-c-virus"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["nci","asco"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-enrolment","b-trial-diversity"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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.","test":"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","actor":"industry","cost":"small","horizonYears":2},"route":"/ideas/idea-tr1-prior-cancer-hiv-hepatitis-inclusion/","neighbours":{"institution":[{"id":"asco","kind":"institution","name":"American Society of Clinical Oncology (ASCO)","route":"/institutions/asco/"},{"id":"nci","kind":"institution","name":"National Cancer Institute (NIH)","route":"/institutions/nci/"}],"bottleneck":[{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}]}}