The current regulatory framework for clinical trials was designed for a different era, when the technology of the time mandated centralization of activities that gravitated toward major research institutions, and less emphasis was placed on access to patients who were representative of the population with the diseases being studied. Diversity in research is a high priority, and modernization of clinical trials is key to improving enrollment of participants from underrepresented racial and ethnic populations and increasing access to care. Innovations in technology and trial design have the potential to unlock a new era of clinical research that is more convenient for patients, more reflective of real-world treatment conditions, and more likely to enable participation of a diverse set of individuals. This session will examine how modernized approaches to key regulatory and legislative policies could accelerate the availability of new and breakthrough therapies to patients in need. 

CEU: 1.00 ACRP

Speakers:

• Sara Edwards, Senior Director, Decentralized Design & Delivery Integration, Eli Lilly and Company

• Stacy Holdsworth, PharmD, Associate Vice President, US Regulatory Policy & Strategy, Eli Lilly and Company