Meeting Scope:

• Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
• Real-World Evidence (RWE) is the clinical evidence regarding the usage, and potential benefits and risks, of a medical project derived from analysis of RWD.
• The focus of this meeting and project is to explore the appropriate use of electronic health records and payment claims (RWD) in randomized clinical trials (RCTs) to generate RWE to support regulatory decision-making.

Meeting Objectives:

• Present findings from evidence gathering activities.
• Identify barriers and potential solutions to generating RWE for regulatory submissions from these RWD sources.
• Describe what recommendations and resources CTTI should develop to equip change agents to increase appropriate use of RWD in RCTs, including to support regulatory submissions.

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

1. Introduction to the Clinical Trials Transformation Initiative (CTTI) by Pamela Tenaerts
2. Issue, Project Overview, and Meeting Objectives by Gerrit Hamre
3. Qualitative Interview Findings by Jack Sheehan
4. Use of RWD in Pre-Study Planning and Study Set Up Session Introduction by Jane Perlmutter
5. Use of RWD in Pre-Study Planning & Study Set up: Health Plan Perspective by Kevin Haynes
6. Use of RWD in Pre-Study Planning & Study Set up: Manufacturer Perspective by Ben Gutierrez
7. Using the Cystic Fibrosis Patient Registry to Support Clinical Trials Planning by Aliza Fink
8. Use of RWD in Study Recruitment and Enrollment: EHR Enabled Platform by James Hamrick
9. Patient & Site Identification Using an EMR Data System by David Thompson
10. Real-World Treatment Responses in Advanced NSCLC Patient Subgroups by Michael Lu
11. Real World Data Use in Embedded Pragmatic Clinical Trials by Sarah Leatherman
12. Use of Real-World Data within ADAPTABLE, The Aspirin Study by Brad Hammill
13. Day One Recap and Discussion of Priority Insights by Khair ElZarrad