FDA finalizes guidance on placebos and blinding for cancer trials
The FDA on Wednesday finalized guidance recommending that drugmakers only use placebos in cancer clinical trials in select circumstances due to ethical concerns that would arise when alternative therapies are available.
According to guidance, placebos should only be considered in randomized controlled trials to treat oncologic disease or hematologic malignancy “when surveillance is standard of care” or in studies with “certain trial design features (e.g., when the trial uses an add-on design).”
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