Due to unforeseen circumstances, FierceBiotech has decided to cancel this event.
Getting Real: The Changing Tide on Real-World Evidence in Drug Development
FDA is opening up to data gathered outside the hermetically sealed clinical trial setting as regulators recognize the need for a more flexible framework for evaluating treatments, helped along by the 21st Century Cures Act. This move is coinciding with growing expertise among technology providers to tap real-world data sources and analyze them using everything from the latest data-crunching technologies to natural language processing and artificial intelligence.
Real-world evidence teams are cropping up across biopharma as the industry invests in talent and infrastructure to deploy this sort of data in their R&D efforts. They’re using RWE to identify biomarkers that can be used to select clinical trial patients and tapping patient records to help design and optimize trial protocols, plus help identify optimal trial sites. Real-world evidence could also serve as a control arm in certain studies—for instance, rare cancers—to reduce trial duration, allow for a smaller number of participants and save money.
And on the other side of the approval divide, drugmakers are running real-world studies to find and tap new marketing and payer insights, including long-term safety and outcomes.
As a new approach that requires significant investment, real-world evidence requires the right talent and technology. Where to find that talent and technology, and how to deploy it internally or with partners, are some of the questions companies face. We’ll address these questions and more with the help of current experts and practitioners in the field.
Stay tuned for speaker announcements in the coming weeks!
Session ID: 549578