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.
- 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.
Pages like this
not linked directly; found by shared links- IdeaLay trial navigators funded per centre, evaluated in a randomised trial
Shares American Society of Clinical Oncology (ASCO), Trials do not represent the people who get cancer, Trials enrol too few, too slowly, National Cancer Institute (NIH).
- IdeaCommunity health workers and trusted local organisations paid to recruit for trials
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly, National Cancer Institute (NIH).
- IdeaAt least a third of pivotal-trial sites in community and rural settings
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly, National Cancer Institute (NIH).
- IdeaRemove blanket exclusions for mental illness and dementia; support consent instead
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly, National Cancer Institute (NIH).
- IdeaMobile research units bring trial visits to rural towns
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly, National Cancer Institute (NIH).
- IdeaDefault-inclusive eligibility: sponsors must justify every exclusion criterion
Shares American Society of Clinical Oncology (ASCO), Trials do not represent the people who get cancer, Trials enrol too few, too slowly, National Cancer Institute (NIH).
- IdeaEvery payer covers routine care costs for trial participants, in every country
Shares American Society of Clinical Oncology (ASCO), Trials enrol too few, too slowly, National Cancer Institute (NIH).
- IdeaA public equity index for trial sites and sponsors, tied to funding
Shares American Society of Clinical Oncology (ASCO), Trials do not represent the people who get cancer, National Cancer Institute (NIH).