Diversity action plans with consequences: unmet targets trigger post-approval requirements
Companies now have to file a plan for enrolling a representative mix of patients. If the trial misses the plan, the label should say so and the company should be required to fill the gap after approval.
Under the US FDORA requirement for diversity action plans, sponsors set enrolment goals by race, ethnicity, sex and age. The proposal adds teeth: the approved label states enrolled demographics against disease incidence; shortfalls beyond a threshold trigger a post-marketing requirement for a supplementary study or registry in the under-enrolled group with a deadline; and repeat shortfalls are published in an annual sponsor scorecard.
- 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.
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not linked directly; found by shared links- IdeaPrint the participation-to-prevalence ratio in every drug label and assessment report
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Trials do not represent the people who get cancer.
- IdeaCommunity health workers and trusted local organisations paid to recruit for trials
Shares Trials do not represent the people who get cancer, 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, 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, National Cancer Institute (NIH).
- IdeaMobile research units bring trial visits to rural towns
Shares Trials do not represent the people who get cancer, National Cancer Institute (NIH).
- IdeaPaid community advisory boards with power to change protocol burden
Shares Trials do not represent the people who get cancer, National Cancer Institute (NIH).
- IdeaA public equity index for trial sites and sponsors, tied to funding
Shares Trials do not represent the people who get cancer, National Cancer Institute (NIH).
- IdeaLay trial navigators funded per centre, evaluated in a randomised trial
Shares Trials do not represent the people who get cancer, National Cancer Institute (NIH).