Drugs

Improving Trial Representation Book

The National Academies of Science, Engineering, and Medicine has published Improving Representation in Clinical Trials, with recommendations for building research equity for women and underrepresented groups. The report (free PDF or purchase) says there is no doubt that past investments in clinical research to improve the health and well-being of the nation have contributed significantly to treating and preventing disease and extending human life

“While progress has been made with representation of white women in clinical trials and clinical research, there has been little progress in the last three decades to increase participation of racial and ethnic minority population groups,” the report says. “This underrepresentation is compounding health disparities, with serious consequences for underrepresented groups and for the nation.”

The report says that by failing to achieve a more diverse clinical trial and clinical research enterprise, the nation suffers these serious costs and consequences:

lack of representation compromises generalizability of clinical research findings to the whole U.S. population;
lack of representation costs hundreds of billions of dollars;
lack of representation may hinder innovation and new discoveries;
lack of representation may compound low accrual that causes many trials to fail;
lack of representation may lead to lack of access to effective medical interventions;
lack of representation may undermine trust in the clinical research enterprise and the medical establishment; and
lack of representation compounds health disparities in the populations currently underrepresented and excluded in clinical trials and clinical research.

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