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Before a company runs its phase 3 cancer trial, FDA, EMA, MHRA, PMDA, Health Canada and TGA would agree the endpoints, comparator, population and statistical plan in one joint written advice letter, so a single trial can support approval everywhere. Today parallel advice is used for a handful of products a year.
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.
Shares Regulatory divergence between regions, Trial design, endpoints and cost.
Shares Regulatory divergence between regions, Trial design, endpoints and cost.
Shares Regulatory divergence between regions, Trial design, endpoints and cost.
Shares Regulatory divergence between regions, Trial design, endpoints and cost.
Shares Regulatory divergence between regions, Trial design, endpoints and cost.
Shares Regulatory divergence between regions, Trial design, endpoints and cost.
Shares Regulatory divergence between regions, Trial design, endpoints and cost.
Shares Regulatory divergence between regions, Trial design, endpoints and cost.