Drugs

Data Monitoring Committees Need Flexibility: Study

Researchers from the University of Wisconsin and the University of Pennsylvania report in the New England Journal of Medicine that data monitoring committees (DMCs) need to be prepared for the unexpected in the drug trials they monitor. “DMCs play a critical role in the conduct of clinical trials by assessing the risks and benefits of an intervention as data accumulates, thereby enhancing the safety of trial participants,” the report says. “Although the fundamental principles of DMCs have been described, trials can present challenges for the DMC that are not anticipated or covered in the DMC statistical analysis plan. DMCs have to be prepared for the unexpected, relying in large part on their experience and collective wisdom.”

In most cases, the authors say, trials are completed as planned, with no DMC recommendation for early termination or major modification, but some trials have raised challenges for DMCs. The article includes summaries of “a few classic cases of early termination” and then addresses some recent cases to further illustrate the complexity of DMC responsibilities.

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