Foley & Lardner Partner Monica Chmielewski will join executive leaders from Walgreens, AbbVie, and Cardinal as part of the Healthcare Business Women's Association to discuss how their organizations are using Real-World Data (RWD) to move the needle on clinical trials to improve access to medications.
Today, clinical research, and the data collected within it, need to be more reflective of the real-world settings in which patients live, so that providers can better close care gaps and improve outcomes. As such, RWD is playing an increasing role in healthcare and regulatory decision making, especially as the US Food and Drug Administration (FDA) is more open to accepting RWD to support its assessment of medical products. However, RWD stakeholders lack a shared understanding of the FDA?s expectations for the use of RWD in applications and research for new drugs and biologics. As the healthcare and life sciences industry further develops common standards, structures and processes around RWD generation, consideration must be made to use cases that support the FDA's recent steps to increase racial and ethnic diversity in clinical trials.