The desire for RWD/RWE by global regulators to demonstrate medical device safety and efficacy is growing. We exist in an era of unprecedented technological capabilities for data linking, tokenization to protect privacy, and big data analytics. However, many challenges remain with the use of these data for medicines and device evaluation. Data quality, common data models, alignment on statistical methodologies, data linkage technology, data access and privacy, stakeholder agreements for data sharing, patient input and consent, and ethical concerns persist. Regulators must collaborate such that industry can leverage these capabilities in a least burdensome way and ensure RWE is used to effectively and efficiently get innovative medicines and technologies to patients around the world.
Read MoreDozens of papers, workshops, and white papers have been published in the last few years addressing the myriad of challenges and opportunities associated with the use of real-world evidence (RWE) as evidence of medical product safety and effectiveness. This quarter, I will be teaching the first course addressing real-world evidence in biomedical research for Northeastern University's online graduate regulatory affairs program. The wealth of information available on all facets of real-world evidence use is nearly overwhelming. Yet, it remains unclear whether we can effectively harness the volumes of available data in an ethical and effective manner.
Read More