Last week, Vinay Prasad and Martin Makary published a landmark piece in the New England Journal of Medicine announcing that the FDA’s new default standard for marketing authorization will be one adequate and well-controlled clinical trial, supported by confirmatory...
When the Supreme Court changes a legal standard, the system adjusts. When the FDA changes a regulatory default, the drug development ecosystem recalibrates. Last week’s FDA decision to make one adequate and well-controlled trial the default, supported by confirmatory...
Real-world evidence is critical for understanding how therapies perform beyond controlled clinical trials. Yet many life sciences organizations rely on fragmented proprietary data that lack the longitudinal clinical context needed to support regulatory, payer, and...
In this Truveta experts analysis, Amy Sullivan, MS examines real-world antidepressant prescribing episodes using linked electronic health record (EHR) and closed claims data from more than 14.5 million individuals. The analysis characterizes the duration, recurrence,...
Two new peer-reviewed studies published in the Journal of Cardiac Failure showcase how clinicians and researchers at Baylor Scott & White Research Institute, working in collaboration with Baylor Scott & White Health and Stony Brook Medicine investigators, are...
A large proportion of early users (36.1%) of oral semaglutide (Wegovy pill) had no prior evidence of GLP-1-based medication use, suggesting rapid uptake among patients new to taking GLP-1 medications. Among patients who previously used a GLP-1-based medication, most...
Authors: Duy Do, PhD⊕Truveta, Inc, Bellevue, WA, Karthik Murugiah, MD ⊕Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT,...
Hematologic oncology is at an inflection point. Over the past decade, innovation in blood cancers has accelerated dramatically. Breakthroughs like CAR-T and next-generation immunotherapies have redefined what’s possible for patients with blood cancers, turning...
In this Truveta experts analysis, Karen Gilbert Farrar, PhD examines the relationship between sleep disorders and mental health conditions among adolescents using Truveta’s de-identified electronic health record (EHR) data. The analysis focuses on patients ages 12–17...
New peer-reviewed research published in the Journal of Cardiac Failure offers promising real-world evidence on long-term survival after cardiac contractility modulation (CCM), a device-based therapy for patients with symptomatic heart failure who are not candidates...
Clinical trials remain one of the most resource-intensive stages of drug development. Slow enrollment, protocol amendments, zero-enrollment sites, and incomplete real-world evidence can delay timelines and increase cost—ultimately slowing access to life-changing...
