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Background

To support the goal of expediting the development of drugs and biological products for the treatment of MDS, the FDA Oncology Center of Excellence (OCE) in coordination with the NCI, is convening a public meeting to advance the discussion around optimal design of clinical trials for patients with MDS. 

Meeting Goals

• Discuss key eligibility considerations and risk stratification on MDS clinical trials 
• Discuss optimal definitions of MDS clinical trial endpoints
• Present available evidence to support new endpoints for clinical trials in MDS. 

Workshop Materials

Contacts

Laura Wisch, MSN, RN
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
Tel: 301.538-6580
laura.wisch@fda.hhs.gov

Erin Purcell, RN
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
Tel: 240.479.8164
Erin.purcell@fda.hhs.gov