Joint FDA-EMA-MHRA-PMDA scientific advice by default before pivotal cancer trials
Before a company runs its big trial, all the major regulators should agree together on the design in one meeting, so the same trial can be approved everywhere.
FDA-EMA parallel scientific advice exists but is used for a handful of products a year. The proposal is to make a joint written advice procedure covering endpoints, comparator, population and statistical plan the default for phase 3 oncology programmes, with PMDA, MHRA, Health Canada and TGA as standing participants. Advice would be recorded as a single agreed letter identifying any residual divergence, and divergence would be published in aggregate.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
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- IdeaA standard for tumour-agnostic approvals: minimum histologies and hierarchical modelling
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- Key paperPrasad: most surrogate endpoints in cancer trials correlate poorly with survival
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- CollectionESMO Clinical Practice Guidelines & MCBS
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- CollectionFDA Oncology Approvals (OCE) & Novel Drug Approvals
Shares Regulatory divergence between regions, Trial design, endpoints and cost.