We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Fifteen FDA officials, including Commissioner Robert Califf, called for broader uses of research methodologies, such as intervention and randomization, in real-world settings outside the typical venues of clinical trials. Read More
The lowest-cost patient-centered initiatives — such as involving advisory groups and offering patient counseling and education — led to the largest returns in clinical trial performance. Read More
The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More
Clinical trial design in non-muscle invasive bladder cancer should depend on whether patients have active disease at the time of enrollment, the FDA said, in a draft guidance that focuses on developing drugs and biologics for disease that has not responded to standard bacillus Calmette-Guerin immunotherapy. Read More