Real-World Database Studies: Prepare For A Long Journey, IQVIA Advises
Executive Summary
Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.
You may also be interested in...
PDUFA VII: Will Gene Therapy's Rise Influence Talks?
The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.
US FDA Data Strategy Will Cover Security For Internal Sharing
FDA seeks expert comments during an upcoming public meeting on strategies to facilitate various centers combining and sharing data.
Real-World Evidence: Sponsors Look To US FDA Drug Reviews For Potential Pitfalls
Methodological problems with RWE submissions for approved applications may give sponsors ‘a little bit of a pause’ as they work through data selection and analytical issues, Aetion’s Jeremy Rassen says. CDER’s Janet Woodcock says it is easier to use RWE when treatment effects are large.