Drugs

Califf Wants More Clinical Trial Education

Former FDA commissioner Robert Califf told a 3/14 Clinical Trials Transformation Initiative webinar that better educational efforts are needed so that everyone in the clinical trial chain understands the entire process and not only their own role during a specific trial segment. In a presentation entitled “A Viewpoint on the Current State of Clinical Trials and the Path to Transformation,” Califf said that the clinical research enterprise is poised for “transformational progress” but is hampered by wariness over technology, miscommunication between industry and regulators, and a lack of education. “It’s time to take it to the next level,” he said, according to an Association of Clinical Research Professionals blog post.

Califf said the medical industry was “one of the last” to harness technology, which represents another barrier to improving trial efficiency and patient engagement. “We have to figure this out,” he declared.

Phase 1 trials don’t employ the best technology available, Califf explained, which means that most information is lost from such studies, since most medical products fail during development. He said he hopes that increased transparency will help to overcome such challenges.

The current system, he said, is not delivering adequate evidence in the face of an “explosion” of new medical products and increased understanding of how to evaluate products already in clinical use, major changes in delivery and payment systems, and increasing awareness of disparities.

“A decade ago, there was a sense of frustration with the clinical trials enterprise,” Califf concluded. “I’m still frustrated, but looking back, we’ve made real progress and transformational progress is now in sight.”

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