Posted by Michael Wonder on 28 Aug 2019
Placebos and blinding in randomised controlled cancer clinical trials for drug and biological products: guidance for industry
28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical trials in development programs for drug or biological products to treat haematologic malignancies and oncologic diseases.
This guidance does not address the statistical analyses that can be considered when data are unblinded in these trials.
