Need a placebo control group for your next cancer drug study? Only in certain circumstances, says FDA
Given the ethical challenges of using a placebo in randomized controlled clinical trials for therapies to treat hematologic malignancy and oncologic disease, the FDA recommends that a sponsor use a placebo-controlled design only in select circumstances, according to new draft guidance released Thursday.
Such circumstances include “where surveillance is standard of care,” or with specific trial “design features (e.g. if the trial uses an add-on design, when the endpoint intended to support a labeling claim has a high degree of subjectivity, such as patient reported outcomes).”
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