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Twitter: #OCE2021HNSCC

Sponsored by the U.S. Food & Drug Administration (FDA)

Background:

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) welcomes you to the Clinical Trial Endpoint Development for Locally Advanced Head and Neck Cancer public virtual workshop. Throughout the day you will hear interactive discussions on early endpoints in locally advanced head and neck squamous cell carcinoma, event-free survival (EFS) and locoregional control (LRC), issues regarding management and defining early endpoints, and patient’s perspective on clinical trial endpoints.

Meeting goals:

• Provide a forum for open discussion between academia, regulatory, and patient advocacy groups on clinical trial endpoint development for locally advanced head and neck cancer.
• Identify the current status of early endpoints for locally advanced head and neck cancer and how it differs from other cancers.
• Engage stakeholders to identify concerns regarding standardization of endpoint definitions and clinical trial design.

Workshop Materials

• Agenda (PDF 168KB)
• Biographies (available soon)
• Session I: Clinical Trials in Non-Metastatic HNSCC
• Session II: Defining Early Endpoints and Issues Regarding Management After Definitive Therapy
• Session III: Patient Perspective on Clinical Trials for Locally Advanced HNSCC
• Session IV: Early Endpoints in Locally Advanced HNSCC
• Session V: EFS as an Endpoint in Locally Advanced HNSCC Clinical Trials
• Session VI: LRC as an Endpoint in Locally Advanced HNSCC Clinical Trials
• Session VII: Patient Reported Outcomes

Webcast Information:

A free-of-charge webcast of this public panel discussion will be provided. Registration for the webcast is required at the link above.

FDA plans to post archived webcasts after the meeting, however, in cases where the transmission was not successful, archived webcasts will not be available.

Event Point of Contacts

Angela James, RN, MSN
Senior Regulatory Health Project Manager
Oncology Center of Excellence
Office of the Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue, Silver Spring, MD 20993
Tel: 301-796-6122
[email protected]

Christine Lincoln, RN, MS, MBA
Senior Regulatory Health Project Manager
Oncology Center of Excellence
Office of the Commission
U.S. Food and Drug Administration
10903 New Hampshire Avenue, Silver Spring, MD 20993
Tel: 301-796-4117
[email protected]