Drugs

Study Faults Academic Center Trial Dissemination

Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in disseminating clinical trial results across leading academic medical centers, according to research published online in the open-access BMJ. Researchers from Yale and several other major universities looked at 4,347 interventional clinical trials across 51 academic medical centers. They found that only 29% of completed clinical trials conducted by the faculty at major academic centers were published within two years of completion, and only 13% reported results on ClinicalTrials.gov.

“While seemingly axiomatic that the results of clinical trials led by the faculty at leading academic institutions will undergo peer-reviewed publication, our study found that 44% of such trials have not been published more than three, and up to seven, years after study completion,” the report says. “This is consistent with previous studies that have reported between 25% and 50% of clinical trials remain unpublished as much as several years after completion.”

The researchers conclude that the lack of timely reporting and publication fundamentally impairs the research enterprise, violates the commitment made by investigators to patients and funders, squanders precious time and resources, and threatens to compromise evidence-based clinical decision-making. They call for additional tools and mechanisms to rectify the lack of timely reporting and publication.

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

Read more

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