Stop over-excluding people who could become pregnant; study pregnancy exposure
Trials often impose heavy contraception rules and exclude anyone pregnant or breastfeeding, even when the drug is unlikely to be harmful. Sensible, evidence-based rules and pregnancy registries would include more young women and produce data they currently lack.
Contraception requirements are set from the drug's actual reproductive toxicology rather than a blanket 'two highly effective methods'; breastfeeding exclusion is replaced by lactation PK studies where feasible; and pregnancy exposure registries are funded for oncology drugs so that the inevitable exposures generate data. Adolescent and young adult women are disproportionately affected by current rules.
- 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.
- 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.
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not linked directly; found by shared links- IdeaFix the neutrophil count rule that excludes many people of African ancestry
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly, Triple-negative breast cancer (TNBC).
- IdeaPay trial participants for their time, not only their expenses
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly.
- IdeaTravel, lodging and meals reimbursed as a standard line in every trial budget
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly.
- 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.
- 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.
- 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.
- 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.
- IdeaDrop the 'must speak English' rule: translated consent and questionnaires as standard
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly.