Default-inclusive eligibility: sponsors must justify every exclusion criterion
Trials should let people in unless there is a scientific or safety reason to keep them out. Every exclusion rule would need a written reason, reviewed like the rest of the protocol.
Regulators and ethics committees would require a one-line scientific or safety justification for each exclusion criterion, with a default set of permitted criteria (the ASCO-Friends of Cancer Research broadened criteria on brain metastases, organ function, prior malignancies, HIV and hepatitis) needing no justification and anything stricter needing one. The FDA's 2020 eligibility guidances describe what is reasonable; this idea makes the reasonable set the default and puts the burden of proof on restriction.
- 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).
- IdeaStop excluding people with a prior cancer, controlled HIV, or treated hepatitis
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).
- 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).