Randomized Study Objectives Should Drive Choice Of Real-World Data Sources, Experts Say
Start with the trial’s primary objective and then figure out which RWD sources could help inform that outcome, experts say at Duke-Margolis meeting; however, design and underlying objectives of Novo Nordisk’s real-world use of trial of Ozempic have the FDA’s Robert Temple suggesting success will be a ‘longshot.’
You may also be interested in...
CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.
Full results from asthma patients included in the Salford Lung Study provide powerful support for the use of “real world” effectiveness studies as a more relevant form of evidence to inform prescribing choices and improve patient outcomes, particularly in what turned out to be a general population of asthmatics that were still suffering symptoms under usual care.
The Salford Lung Study is pioneering in the emerging field of gathering real-world evidence. David Leather, Global Medical Affairs Leader in the Respiratory Franchise at GSK, led the UK-based study and talked to the Pink Sheet about why it was important for GSK and what may come next.