RWE: Bridge Between Clinical Research & Practice?

What IS real-world evidence? Who owns it, and how do we define, collect, analyze and use it? DIA EuroMeeting 2017 explored these questions in the DIAmond session Major Regulatory Challenges Enabling Decision Making for Early Patient Access: Regulatory Tools and Sources of Real-World Evidence. “After the initial assessment of a medicine, medicines are being used by health care providers and patients across the globe to treat illnesses. And we don’t seem to have a good way of collecting the data from that actual use in those settings to help us learn and refine our knowledge about the safety and effectiveness of medicine,” explains Session Chair Dr. Sandra Kweder, Deputy Director in the FDA Office of International Programs’ Europe Office, and Liaison to the European Medicines Agency, in this exclusive Global Forum podcast. “The concept of real-world evidence seeks to bridge those two spheres of inquiry.” Dr. Kweder will be featured speaker in several DIA 2017 Global Annual Meeting sessions.