Placebos and blinding for cancer trial receive finalized guidance by the FDA


The U.S. Food and Drug Authority (FDA) released a finalized guidance on the cancer trials, recommending that only Placebos should be used in case of select circumstance, taking into account, the ethical reasons that may arise during the availability of other alternative options.

The guidance suggests that placebo should be used to treat in case of oncology diseases 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).”  The FDA further adds, “A placebo-controlled study design may be useful or preferred in maintenance therapy, in add-on trial designs, in trials of adjuvant therapies (for which standard of care is surveillance), and for indications where no treatment is available.”