Posted by Michael Wonder on 31 Aug 2021
Real world outcomes associated with new cancer medicines approved by the FDA and EMA: a retrospective cohort study
August 2021 - Real world data studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice for novel cancer drugs. However, few studies have systematically appraised their quality or compared outcomes to pivotal trials.
Real world data study quality for novel cancer drugs is low and of insufficient rigour to inform reimbursement decisions and clinical practice.
Real world data studies seeking publication should provide a completed quality assessment tool on submission.
