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...
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...
Healthcare is changing in front of us. Data, intelligence, and clinical insight are finally converging in ways many of us have been working toward for decades. For the first time, we can begin to understand patient journeys as they actually unfold—not in fragments,...
