Slower Clinical Trial Timelines Hinder Drug Approval Process

Average total time to conduct clinical studies and then complete the approval phase increased by 4.8 months from 2008–13 to 2014–18, according to a new report by the Tufts Center for the Study of Drug Development (CSDD), with mean clinical times increasing by nearly seven months and approval times dropping by nearly two months. […]

Rho Works to Promote Clinical Trial Patient Diversity

While anecdotal evidence and data from the U.S. Food and Drug Administration (FDA) suggest progress has been incremental at best, former clinical research associate (CRA) Sharon Duffy remains “optimistic” that raising awareness of the nagging lack of diversity in clinical trial patient populations is going to ultimately prevail, and make trials more representative of the […]

NIAID Launches Network to Expand COVID-19 Clinical Trial Testing

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has established a new network that aims to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19. The COVID-19 Prevention Trials Network (COVPN) was […]

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FDA Eyes Imminent Resumption of Physical Inspections

The U.S. Food and Drug Administration (FDA) is “working toward the goal of restarting onsite inspections during the week of July 20,” Commissioner Stephen M. Hahn, MD, said on July 10. “However, resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality, and the rules […]