With regulators and industry focused on diversity action plans, diversity, equity and inclusion (DE&I) is poised to be a huge priority this year. A recent survey reveals what is and isn’t working for sites on diversity tactics and how sponsors can best lend a hand.
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Regardless of size, sites can implement many patient-centric changes without significant costs, and inexpensive ones can actually have a very positive impact, according to DM Clinical, a U.S. site network that’s earned praise for its lower-cost, data-driven approach to putting patients first.
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The FDA says trial sponsors and investigators may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance.
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A new FDA draft guidance for sponsors developing drugs to treat early Lyme disease focuses on trial designs for treatment of erythema migrans, a rash that often appears as one of the first symptoms in the disease’s early stages.
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Sponsors still are falling behind in their postmarket reporting, according to the FDA’s yearly update on progress of postmarketing requirements/commitments.
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In the latest push for data interoperability in drug research, the Pistoia Alliance, a nonprofit aimed at encouraging collaboration among industry stakeholders, has published a guide for data standards that would make research data shareable among sponsors, clinical trial sites and regulators.
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