Guide on Hematologic Malignancy and Oncologic Drug Trials

Federal Register notice: FDA has made available a draft guidance entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.” The agency says that for patients with hematologic malignancies and oncologic diseases that have standard effective therapy available, use of a placebo (not an active treatment) poses ethical issues. If possible, an active control is often preferred over placebo, and one option has been to conduct an open-label trial with a physician’s choice of one of a few standard therapies as the comparator. Another option has been to compare the investigational drug product to placebo, with each added to the standard of care (an add-on trial).The draft guidance provides recommendations to industry about such trial designs. To view the guidance, click here. To view the notice, click here.