Drugs

CDER Statisticians Working on Adaptive Clinical Trials

CDER says its statisticians are designing clinical trials with adaptive features to make clinical evaluation of new drug treatments more efficient and informative. In an online Regulatory Science Impact Story, Center officials describe the challenges involved in evaluating treatments for Ebola during the outbreak a few years ago.

“A randomized trial is essential for collecting conclusive evidence about the relative benefits of treatments,” the article says, “but it is difficult to conduct trials in the context of an epidemic, in part because it would be unethical to withhold potentially effective treatments from patients.

In the Ebola trial, CDER says, patients were randomly assigned to what was then the optimized standard of care or that care plus investigational treatments for which promising nonclinical evidence existed. To further address ethical concerns of withholding effective treatment from patients, the trial was designed so that if a treatment proved efficacious, it could become the new standard of care for all trial participants. Also, the Center says, investigators could add or drop raw investigational treatments as information became available.

The article also discusses other innovative trials being developed by CDER statisticians that meet precision medicine challenges.

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