Drugs

2 ‘Influencers’ Call for Using More RWD in Trials

Writing in a MedCity News “influencers” online post, Susan Dallabrida and Craig Gravina say that while researchers have been talking about the potential benefits of using real-world data (RWD) in clinical trials, it has been difficult to accomplish. “The primary reason is that RWD has been largely unavailable to clinical trial teams, hindered by patient privacy, regulatory restrictions, and disparate data structures,” they write. “While there have been notable successes in using available electronic health records and claims data, deeper and more valuable clinical data has been inaccessible.”

Dallabrida and Gravina say that liberating the genetics, laboratory, and pharmacy data that sit deep within healthcare subsystems, while protecting patient information and navigating the global regulatory landscape, is no easy task. “But,” they say, “considering the upside of getting real-world evidence right, the effort is more than worth it.”

The post describes several steps that could be taken to expand the use of RWD and concludes that despite the challenges, there is a consensus in the industry that RWD will be integral to the future of clinical trials, with the potential to deliver more robust findings and increase the return on investment in health innovation. “The onus is on the health community to develop the necessary guardrails, collaborations, and tools to deliver less hype and more results,” they write.

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