The Future of Registries in Oncology

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Date: August 27 – 28, 2025 Day1: Wed, Aug 27 10:00 a.m. – 01:00 p.m. ET Day2: Thu, Aug 28 10:00 a.m. – 01:00 p.m. ET

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Background

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) will host a two-day virtual public workshop to bring together all interested parties to discuss ongoing efforts and future directions in registry development in oncology, with a specific focus on the malignant pediatric brain tumor, Diffuse Midline Glioma (DMG)/Diffuse Intrinsic Pontine Glioma (DIPG). Day 1 will introduce relevant concepts regarding registry data and common data elements, including examples of registries which have supported regulatory decision making in oncology. Day 2 will focus on the ongoing efforts to build national and international registries of patients with DMG/DIPG, with forward-looking discussions regarding registry “best practices” for this rare, life-threatening cancer. The goals of this workshop are to provide a first step in a longitudinal effort to optimize registry development in DMG/DIPG, and to encourage the collection of fit-for-use, high-quality registry data that could potentially support novel therapeutic development for patients with DMG/DIPG.  

Meeting Goals

• Review examples of existing registries that have successfully supported drug development in oncology. 
• Discuss foundational concepts for oncology registry development, including common data elements, best practices for data collection and management. 
• Assess the current state of national and international efforts to build patient registries for pediatric DMG/DIPG. 
• Facilitate forward-looking discussions on optimal registry design and implementation strategies, encouraging the development of data collection processes and data quality standards that could support future therapeutic development initiatives. 
• Establish this workshop as the first step in an ongoing, multi-stakeholder effort to optimize DMG/DIPG registry development. 

Meeting Information

This is virtual public event requiring registration. 

Registration 

REGISTER HERE

Workshop Materials

• Agenda (Pending)
• Biographies (Pending)

Contact

Angela James, MSN, RN 
Senior Health Scientist 
Oncology Center of Excellence (OCE) 
Office of the Commissioner (OC) 
U.S. Food and Drug Administration 
10903 New Hampshire Ave | Silver Spring, MD 20993 
Office number: 202-0317-0312 
Angela.james@fda.hhs.gov
 

• Content current as of:

  08/05/2025

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