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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.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Trials do not represent the people who get cancer.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on.
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.
Shares Trials do not represent the people who get cancer, National Cancer Institute (NIH).
Shares Trials do not represent the people who get cancer, National Cancer Institute (NIH).
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on.
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 Trials do not represent the people who get cancer, National Cancer Institute (NIH).