Drugs

Final Guide on Placebos/Blinding in Cancer Trials

FDA has released a final guidance entitled “Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.” The document provides recommendations to industry about placebos and blinding in development programs for products to treat hematologic malignancies and oncologic diseases. It does not address the statistical analyses that can be considered when data are unblinded in such trials.

The guidance says that because of the toxicity profile of an active treatment, patients and investigators may infer which treatment patients are receiving, “so using a placebo control may not blind the treatment. For patients with hematologic malignancies and oncologic diseases that have standard effective therapy available, using a placebo (not an active treatment) generally would not be considered ethical, so an active control trial should be conducted. One such active control superiority trial design option is to conduct an open-label trial with a physician’s choice of one of a few standard therapies as the comparator. In open-label comparative trials for which investigator bias may be of concern, a blinded central independent review of scans may mitigate bias regarding endpoint assessment. Another option has been to compare the investigational drug product with the placebo, with each added to the standard of care (an add-on trial).”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome