Drugs

Clinical Trial Covariates Guidance

FDA has published a draft guidance, Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes, to give the agency’s recommendations for adjusting for covariates in randomized clinical trials with continuous endpoints that are appropriate for analysis with normal-theory methods, such as the two-sample t-test. The document says nonparametric methods, categorical outcomes, and survival methods, among others, are outside its scope, although some of the same principles might apply to those methods as well.

“The target population for a new drug usually includes patients with diverse prognostic factors,” the guidance says, “and the population studied in clinical trials should reflect this diversity. However, potential baseline differences between treatment groups in prognostic factors increase the variability of estimates of treatment effects and reduce the power of significance tests. Incorporating prognostic factors in the primary statistical analysis of clinical trial data can result in a more efficient use of data to demonstrate and quantify the effects of treatment.”

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