NIH VideoCast - Leveraging Real-World Evidence to Assess Benefits and Risks of GLP-1-Based Therapies

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Leveraging Real-World Evidence to Assess Benefits and Risks of GLP-1-Based Therapies

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Air date:	Wednesday, May 7, 2025, 9:00:00 AM Time displayed is Eastern Time, Washington DC Local
Views:	Total views: 683 (362 Live, 321 On-demand)
Category:	Conferences
Runtime:	06:30:30
Closed captioning:	Check box to display CC outside of the video Note: You can drag the captioning window around and resize it
Description:	GLP-1-based therapies have transformed the treatment landscape for both obesity and diabetes and offer new options for managing related complications such as major cardiovascular events and obstructive sleep apnea. Growing evidence from clinical trials and observational studies also suggests their potential for the prevention or treatment of multiple other chronic diseases ranging from liver, kidney, and heart disease to addiction, neurodegenerative disorders, and long COVID. With the rapidly increasing use of the relatively new class of GLP-1-based therapies, there is a critical need to identify rare but serious adverse effects, such as cancers and suicidal ideation, as well as health outcomes that may take years to develop and may not be captured in randomized clinical trials or detected through spontaneous reporting systems like the FDA Adverse Event Reporting System. Many questions remain about the use of GLP-1-based therapies in real-world settings, such as optimal treatment pathways for sustainable care, safety and effectiveness in specific subpopulations, heterogeneity of treatment response, and use in a broader range of clinical settings and presentations than those studied in clinical trials. Understanding the impact of GLP-1-based therapies on healthcare costs and benefits helps inform healthcare policy development. Real-world evidence (RWE) using real-world data (RWD) sources, including electronic health records (EHR) and claims data, offer the potential to answer many of these questions but also have significant limitations. In addition, challenges unique to GLP-1-based therapies, such as inadequate insurance coverage, medication shortages, compounded medications obtained outside of the healthcare system, and off-label uses require special consideration. This workshop aims to identify knowledge gaps in the optimal use of GLP-1-based therapies and how they could be addressed using real-world evidence (RWE). Purpose To identify gaps in our knowledge of the benefits and risks of GLP-1-based therapies and how they could be addressed using real-world evidence (RWE) to inform policy and clinical practice decisions. Meeting Objectives At the end of the workshop, participants will identify gaps and opportunities for future research on: Best practices for study designs of GLP-1-based therapies using RWE. Identifying and developing data sources for RWD studies, including strengths and limitations. Best practices for analytic methods to address issues specific to GLP-1-based therapies in studies using real-world data (RWD). Use of RWE in clinical decision-making and clinical guidelines development. Use of RWE for regulatory and healthcare policy decision-making For more information go to https://www.niddk.nih.gov/news/meetings-workshops/2025/leveraging-real-world-evidence-2025

Author:	NIDDK

CIT Live ID:	56751
Permanent link:	https://videocast.nih.gov/watch=56751

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