Series Description

The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
The FDA continues to work around the clock to respond to the COVID-19 pandemic. As part of this effort, we recognize the potential for diverse, real-world data sources such as electronic health records, insurance claims, patient registries and lab results to further inform our science-based, all-of-America response to this unprecedented public health emergency.
In recent years, the agency has taken steps to leverage modern, rigorous analyses of real-world data-such as data from the health care setting-to inform our work. The COVID-19 pandemic has brought an urgency to these efforts and the FDA has worked quickly to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources. Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mitigate potential shortages. These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19.
The FDA is applying data from diverse sources to inform its response to COVID-19, including sources that were already available to the agency, such as Sentinel, BEST, and NEST. The urgency of addressing the COVID-19 pandemic has demanded that we expand our work to identify, access and analyze new datasets to widen the breadth of the information available. This work is being done in collaboration with partners in the U.S. government, academia and industry.
For example, the FDA is an active participant in the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation (RUF) for the FDA in collaboration with Friends of Cancer Research (FOCR). The COVID-19 Evidence Accelerator brings together key stakeholders across the health data ecosystem -spanning academia, government, and private industry – representing scientific expertise alongside data holders, and experts in health data aggregation and analytics. In this novel forum, groups can partner in a unified, collaborative effort to share insights, compare results, and answer key questions to inform the collective COVID-19 response. By developing common data elements and questions, the Evidence Accelerator creates a strong foundation for rapid collection and rigorous analysis of real-world data to answer urgent questions about COVID-19.

References

• N Engl J Med 2016; 375:2293-2297
• Framework for FDA’s Real World Evidence Program: https://www.fda.gov/media/120060/download
• FDA’s real world evidence resource page: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

Series Objectives

• Discuss the research conducted at the FDA
• Explain how FDA science impacts public health

Learning Objectives After completion of this activity, the participant will be able to:

• Explain the mission and goals of the FDA-RUF evidence accelerator collaboration
• Describe the importance of the FDA’s RWE program – past, present, and future - and its uses for advancing RWD/E science, implications for regulatory decision making, and real-time analyses in the context of the COVID-19 public health emergency
• Identify RWD collection methodologies and tools
• Identify optimal use cases for RWD/E and where these data are most fit-for-purpose; describe the use cases to apply the aforementioned methods and tools

Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.

Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

• Abernethy, Amy, MD, PhD, Principal Deputy Commissioner, FDA/Office of Commissioner - nothing to disclose

Planning Committee

• Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
• Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
• Thomas, Devin, LCDR, MPH, CHES, Health Promotions Specialist, FDA/OC/OCS/OSPD - nothing to disclose
• Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team

• Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary; therefore refunds are not applicable.