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The FDA now asks companies to find the right dose of a cancer drug before approval. If every regulator asked the same way, companies would do it once and doses would match worldwide.
FDA's Project Optimus (guidance finalised 2024) expects randomised dose comparison before approval for oncology drugs; other regulators have not formally adopted it, so sponsors face different expectations and may launch different doses in different regions. The proposal is an ICH efficacy guideline codifying dose-optimisation expectations for oncology (randomised comparison of at least two doses, exposure-response, tolerability endpoints) so that one programme serves all regions and approved doses converge.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Sotorasib, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Wrong doses.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Sotorasib, Wrong doses.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Regulatory divergence between regions.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Regulatory divergence between regions.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Wrong doses.
Shares FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high, Wrong doses.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Wrong doses.