Real-World Evidence:
What Researchers Must Know

The role of real-world evidence (RWE) in regulatory, drug development, and clinical decision-making is rapidly expanding. The recent release of FDA’s real-world evidence program framework [December 2018] for evaluating the potential use of RWE in regulatory settings underscores the growing importance of RWE in research. Therefore, clinical trial and drug development professionals need to understand the sources of real-world data (RWD), potential uses of RWE, as well as the limitations and strengths of each approach. This webinar will describe the current state of RWE science and provide context for the regulatory and research implications of RWD and RWE.

Learning objectives:

Define real-world data/real-world evidence (RWD/RWE) and highlight current examples
Describe the features of regulatory-grade RWE and the current FDA RWE framework
Evaluate considerations for the future as RWE continues to evolve, including strengths and opportunities for development

Presented By

Rebecca Miksad

MD, MPH
Senior Medical Director
Flatiron Health

Tim Stoddard

Senior Director, Quality & Regulatory Solutions
Flatiron Health

Who Should Watch?

The content of the regulatory-grade RWE webinar applies to all researchers and staff involved with design, conduct, coordination, monitoring, and interpretation of clinical research. For example, clinical trial sites (institutions as well as unaffiliated sites), sponsors, regulatory groups, CROs, and other research organizations. This topic is of special interest to regulatory stakeholders.

CEU Credits

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

Certificate of Attendance

After completing this webinar in its entirety, you will receive a certificate of attendance. This certificate will include your full name, and it will be emailed to you at the end of the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and take the survey at the end. Visit our Webinar Help page for more information on certificates of attendance.

Duration: 1 hour