Workshop | Virtual
Event Title
The Future of Registries in Oncology
August 27 - 28, 2025
- 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
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
Workshop Materials
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
Event Materials
| Title | File Type/Size |
|---|---|
| FDA Public Workshop - Future of Registries in Oncology Agenda | pdf (139.24 KB) |
| Day 1 Biographies 08272025 | pdf (882.65 KB) |
| Day 2 Biographies 08272025 | pdf (657.48 KB) |