Enrolling less homogeneous patient groups in clinical trials while maintaining safety may lead to a more accurate description of a drug’s safety and efficacy, FDA officials wrote in an article published April 20 in the New England Journal of Medicine.
Shearwood McClelland III’s grandfather was a ditchdigger who dreamed that his six Black daughters would become doctors. McClelland’s mother did not disappoint—she became the first Black woman board-certified in maternal fetal medicine in the history of the United States. Now, McClelland is the chief medical officer of Cancer Health Equity at the University of Oklahoma...
As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments. Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were...
