Drugs

Better Understanding of Heterogeneous Treatment Effects

A 2018 symposium panel with researchers from FDA, Johns Hopkins, and two private companies say the design and analysis of clinical studies play critical roles in evaluating and characterizing heterogeneous treatment effects. A special issue paper in the journal Pharmaceutical Statistics says researchers “can do more or better at understanding heterogeneous treatment effects and providing the best information on heterogeneous treatment effects.” The paper includes information from the several presentations made at the panel session, reactions to the panel presentations, audience questions and panelists’ responses, and conclusion by panel moderator Mark Rothmann from the CDER Office of Biostatistics.

“When we have statistical models to predict individual patient outcomes,” Rothmann said, “we use the data from all subjects. It would make sense that if we wanted to predict treatment effects for individuals or subgroups, we would use the data from all subjects…. More complicated and better models could also be used that include effect modification…. I think we must move away from this dichotomy that we have had of either using the overall population estimate and its corresponding 95% confidence interval or just use the raw subgroup estimate and its corresponding 95% confidence interval…. We should expect different effects across subgroups and individuals.”

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