The 21st Century Cures Act required the Food and Drug Administration to establish a program to evaluate real-world evidence (RWE) for new drug indications and to support post-approval requirements. Several professional organizations have responded by publishing joint statements and white papers promoting enhanced transparency, reproducibility, and usability of RWE studies, including the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the International Society for Pharmacoepidemiology (ISPE), the National Pharmaceutical Council and AcademyHealth.
This seminar will explore how RWE is currently being used. What are the barriers? What is the current status of the use of RWE by the FDA? How can RWE be used to protect patient safety? How can researchers improve their reporting to increase trust? Should registration of observational studies be required? These questions and others will be explored and debated in the seminar.