Drugs

Optimize Emergency Trial Pathway for Public Trust: Study

A review of 41 clinical trials conducted under the FDA exception from informed consent (EFIC) pathway shows that the pathway has been important for the completion of emergency trials and should aim to optimize respect for patients and public trust. A report from Harvard Medical School researchers published online by Health Affairs (purchase required), says the pathway is available for trials conducted on people incapacitated by life-threatening conditions with a therapeutic time window too narrow for reliable surrogate consent. The goals are to promote therapeutic innovation and encourage rigorous but ethical experimentation on that vulnerable population.

The researchers found that of the 46,964 patients enrolled in the 41 trials, 96% were enrolled without consent, and fewer than 1% withdrew before the primary endpoint. Some 8% of the 24 superiority trials demonstrated a benefit from the experimental interventions. Nearly one-third of U.S. patients in the EFIC trials were African American, well above the percentage of the general population and far above the population of clinical trial participants.

“While EFIC trials have yielded medical advances,” the journal article says, “investigators in future trials must pay better attention to managing withdrawals and ensuring fair demographic representation.”

The researchers suggest that FDA consider implementing reporting requirements that would help ensure more rigorous collection and availability of data on consent and race in EFIC trials. “Such data should help policy makers make more informed decisions about the appropriate goals and limits of clinical research in emergency settings and, in turn, improve the EFIC process,” the article concludes.

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