Drugs

FDA Promoting Clinical Trial Patient Diversity: CDER

CDER director of professional affairs and stakeholder engagement John Whyte says the agency has taken steps to promote patient diversity in clinical trials. Writing in a Clinical Leader guest column, Whyte references a 2014 action plan with 27 recommendations in three broad categories: improving the completeness and quality of the demographic subgroup data in medical product applications; identifying barriers to enrolling members of demographic subgroups into clinical trials and using strategies to address the barriers; and making demographic subgroup data more readily available to the public.

Drug Trial Snapshots are released for each new molecular entity within 30 days of approval, he says. They show who participated in pivotal clinical trials used to approve the drug and stratify the data by sex, race, and age subgroups. They also have statements on whether there were any observed differences in safety and efficacy by demographic subgroups at the time of approval.

“Collecting demographic data on sex, race, and age is critical to identifying population-specific signals,” Whyte writes. “Any INDA is required to present annual reports on the participation in clinical trials by age group, gender, and race. As part of their marketing applications, drug sponsors are required to present both safety and effectiveness data by sex, age, racial, and any other subgroups of the population of patients treated, when appropriate. Although there are currently no statutory or regulatory requirements for sponsors to include specific sex, race, or age subgroups as participants in clinical trials, regulations do require presentation and inclusion of analyses of demographic data in marketing applications.”

“By providing the data to begin the conversation on what is the right number of diverse participants to include, where appropriate, FDA is engaging with the scientific community to better understand what health variables are important to capture and may prove to personalize therapies for us beyond our basic demographics,” Whyte concludes. “Additional discussion is needed on ways to improve our understanding of when and why biologic variability in drug response occurs, when it should be measured, and how best to design clinical trials to capture it.”

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