Did you miss this highly rated session at DIA’s 2019 Global Annual Meeting? Here is your chance to hear an encore presentation and engage in live Q&A with Session Chair, Nancy Dreyer.

We see growing interest in the value of using real world data (RWD) to support label expansions and approvals of drugs for rare conditions and oncology products. The FDA released its Framework for Real World Evidence Program in December 2018, following release of its MyStudies App designed to incorporate patient-originated data with other RWD for research purposes. In Europe, the Heads of Medicines Agencies and the European Medicines Agency released a joint report in February 2019 on their big data taskforce summarizing many areas of interest to better understand RWD and its possible uses. We will distill key lessons from demonstration projects and other experience to understand what is being done to evaluate data sets to give confidence in a RW study design, and its findings, including the challenges encountered when comparing data from clinical trials with a medicine’s performance in routine clinical practice, as actually prescribed by physicians and taken by patients.