Drugs

Campaign Needed to Boost Trial Enrollment: Coalition

The Coalition for Clinical Trial Awareness (CCTA) says Congress should include in the PDUFA reauthorization process “an effort to address a pressing public health challenge: lack of public awareness of the benefits of clinical trials leading to under-enrollment.” The request is in a 4/11 letter to leadership of the Senate HELP and House Energy and Commerce committees.

The letter notes that 37% of clinical trials don’t meet their enrollment goals and says that according to the Tufts Center for the Study of Drug Development, 11% of trials fail to enroll even a single patient. “Low participation can delay drug development and increase discovery costs, hindering patient access to life-saving treatments,” the coalition says. “Further, low enrollment of women and minorities in clinical trials makes it difficult to determine the efficacy of a medicine, and can lead to a lack of information about demographic-specific aspects of disease, outcomes, and responses to a therapy.”

The coalition suggests three steps:

form an interagency task force on clinical trial awareness;
create a roadmap based on the task force’s findings; and
implement an information campaign based on the roadmap.

“In past years, federally directed task forces, strategic plans, and information campaigns have successfully addressed important public health challenges, including drug shortages, a regulatory framework for health information technology, and the accessibility of prescription drug container information for Americans with disabilities,” the letter concludes. “CCTA urges members of Congress to use the precedent set by these efforts to launch a similarly structured and equally successful initiative to improve clinical trial awareness and enrollment.”

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