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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.
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).
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).
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Trials do not represent the people who get cancer, Trials enrol too few, too slowly.
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly, National Cancer Institute (NIH).
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly, National Cancer Institute (NIH).
Shares American Society of Clinical Oncology (ASCO), Trials enrol too few, too slowly, National Cancer Institute (NIH).
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Trials do not represent the people who get cancer, National Cancer Institute (NIH).
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Trials enrol too few, too slowly, National Cancer Institute (NIH).