Surrogate endpoints in randomised controlled trials: a reality check

The Lancet

27 July 2019 - At the 24th Congress of the European Hematology Association in June, 2019, the results of the BELLINI trial, a double-blind, randomised, placebo-controlled trial of venetoclax, bortezomib, and dexamethasone versus placebo, bortezomib, and dexamethasone in patients with relapsed, refractory multiple myeloma, were presented.

Earlier, in March, 2019, the US FDA had placed a hold on clinical trials of venetoclax in multiple myeloma.

This action was taken by the FDA after reviewing safety data from the BELLINI trial.

Read The Lancet Commentary

Michael Wonder

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Michael Wonder