Drugmakers seek clarity on guidance on use of placebo and blinding in oncology trials
A half-dozen biopharma companies are seeking further clarity from the FDA regarding draft guidance from August on using a placebo in certain oncology trials.
The draft features the FDA’s thoughts on the ethical challenges of using a placebo in randomized controlled clinical trials for therapies to treat hematologic malignancy and oncologic disease. The draft also discusses blinding and unblinding, patient reported outcomes (PROs) and practical and ethical concerns.
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