Principal investigators, study coordinators and other members of research teams are learning that sponsors are reaping the biggest benefits of decentralized and hybrid trials, such as lower long-term costs. Meanwhile, sites are bearing the burden of up-front costs and increased demands on staff. And evidence that the model has a positive impact on patients is mixed. That’s led some in the research community to wonder: Is the model all it’s cracked up to be?
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Inclusion of appropriately diverse trial participants has been a concern for well over two decades. But in recent years, diversity among clinical trial participants has become a growing concern for sponsors, regulators and researchers alike.
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The FDA has expanded its existing guidance on collecting race and ethnicity data in clinical research to include noninterventional, or observational, studies as well as clinical trials.
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Drugs for cognitively and functionally normal people who have the pathophysiologic changes of Alzheimer’s disease (AD) could be approved on a single biomarker outcome, according to the FDA’s new draft guidance on drug development for early AD.
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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drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind.
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Sponsors have one more year to transfer records on any ongoing trials in Europe to the EU Clinical Trials Information System (CTIS) database.
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