Drugs

Medical Journal Editors Push Data Sharing

Members of the International Committee of Medical Journal Editors say they believe there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a statement published in JAMA, the editors say they remain committed to the goal of data sharing becoming the norm, while acknowledging that the challenges are substantial and the requisite mechanism are not in place to mandate universal data sharing at this time.

To move toward the goal, the editors are requiring these as conditions of consideration for publication of a clinical trial report in member journals:

as of 7/1/18, manuscripts submitted to member journals that report the results of clinical trials must contain a data statement as described in the notice; and
clinical trials that begin enrolling participants on or after 1/1/19 must include a data sharing plan in the trial’s registration.

“These initial requirements do not yet mandate data sharing, but investigators should be aware that editors may take into consideration data sharing statements when making editorial decisions,” the notice says. “These minimum requirements are intended to move the research enterprise closer to fulfilling out ethical obligation to participants. Some member journals already maintain, or may choose to adopt, more stringent requirements for data sharing…. We envision a global research community in which sharing deidentified data becomes the norm. Working toward this vision will help maximize the knowledge gained from the efforts and sacrifices of clinical trial participants.”

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