RWE Steering Committee Meeting Summary - June 13, 2023

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CADTH provided updates on its Scientific Advice program and Post-Market Drug Evaluation. CIOMS shared a report on using real-world data in decision-making. CDA-TO sought input on drug analytics. The committee discussed its mandate and membership for future meetings.


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  1. RWE Steering Committee Meeting Summary June 13, 2023 1:00 p.m. to 2:30 p.m. ET

  2. Agenda Time 1:00 p.m. Topic or discussion item Facilitator Kelly Robinson and Nicole Mittmann (cochairs) Amy Sood Welcome and opening remarks 5 min 1:05 p.m. CADTH Scientific Advice: Update on expanded offering (RWE) 5 min 1:10 p.m. CADTH Post-Market Drug Evaluation Program: Update Tarry Ahuja 10 min 1:20 p.m. Draft CIOMS Working Group XIII report: Real-world data and real-world evidence in regulatory decision-making Open for comment Laurie Lambert 10 min 1:30 p.m. CDA-TO: Introduction to CDA-TO and their activities; input requested from committee on survey Julie Robert 15 min 1:45 p.m. RWE Steering Committee: Discussion on Mandate, Scope, Roles and Responsibilities, Membership, Working Groups and Meetings Farah Husein 30 min 2:15 p.m. Any other business All 10 min 2:25 p.m. 2 Meeting close Melissa Kampman 5 min

  3. Meeting Summary CADTH Scientific Advice provided an update on its program, including a new formalized offering on RWE that was announced in April 2023. CADTH Post-Market Drug Evaluation (PMDE) provided an overview of the types of queries it received. The breadth of queries include a mix of oncology and non-oncology as well as safety and effectiveness questions. A forthcoming dashboard on the PMDE site will publish the queries received. The Council for International Organizations of Medical Sciences (CIOMS) developed a consensus report and recommendations to inform use of RWD and RWE for regulatory and health care decision-making. CADTH participated in the working group for this initiative. The document is now open for public feedback; feedback from the RWE Steering Committee will be coordinated via CADTH. The Canadian Drug Agency Transition Office (CDA-TO) is seeking to leverage data analytics to support decision- making about prescription drugs in Canada. As part of the Pan-Canadian Prescription Drug Data and Analytics Initiative, CDA-TO requested input through an online questionnaire to determine pharmaceutical drug needs and capacity across stakeholders. The committee discussed revisiting the membership and mandate of the RWE Steering Committee, for further discussion over the next few months, with decision-making at the September 2023 meeting. 3

  4. Next Steering Committee Meeting: September 12, 2023, 1:00 p.m. to 2:30 p.m. ET @CADTH_ACMTS linkedin.com/company/cadth facebook.com/cadth.acmts requests@cadth.ca For more information on CADTH RWE team activities, please visit the RWE landing page or contact us at RWE@CADTH.ca. 4

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