Inspired by lackluster efforts to improve diversity, equity and inclusion (DE&I) in clinical research, two centers at the University of Pennsylvania (UPenn) have moved to publish the core methodologies and practices they developed to boost DE&I within their trials.
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In a nod to the increasing potential of demonstrating drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind.
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This week’s Pipeline features a phase 1 trial approval for Rett Syndrome, initiation of two phase 1 and one phase 1/2 trial for solid tumor treatments and eight drug approvals for cancer, hypertension, anemia and metabolic dysfunction-associated steatohepatitis.
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