Drugs

FDA Draft Guides on Adaptive Trials and Master Protocols

FDA has issued two new draft guidance documents — one on adaptive clinical trial designs and the other on master protocols — that propose important principles for modernizing clinical trials through these and similar approaches. “Adaptive clinical trials can give sponsors the flexibility to react to clinical evidence as it’s being collected, and modify the design and enrollment in trials by including more patients with characteristics that help predict that they’re more likely to derive a benefit,” the agency says. Adaptive trials also seek to exclude patients who have certain characteristics that suggest that they’re more likely to suffer a side effect. “By enriching the enrollment in the trial for patients with characteristics that are likely to predict clinical success, it has the potential to make the development process more efficient,” it says. This approach also allows us to potentially learn much more about the characteristics that can inform safer prescribing.”

The master protocols guidance provides recommendations to cancer drug sponsors on the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug or more than one cancer type within the same overall trial structure. It also describes aspects of master protocol designs and trial conduct and related considerations, such as biomarker co-development and statistical analysis considerations, and provides advice on the information that sponsors should submit to FDA and on how sponsors can interact with the agency to facilitate efficient reviews.

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