Bladder Cancer: More Questions Than Answers With pCR Endpoint
Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.
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ctDNA Can Be Used For Patient Selection and Enrichment, But Not As Early Efficacy Endpoint, US FDA Says
More data are required to establish circulating tumor DNA, a blood biomarker, as reasonably likely to predict benefit on long-term outcomes in early-stage, solid tumor trials, agency says in new draft guidance.
With draft guidance allowing for drugs that improve heart failure symptoms but do not improve – or may even decrease – survival, the legal community could help establish development metrics.
CDER director renews US FDA's support for complex trials, but acknowledges that sponsors are still hesitant to adopt them.