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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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FDA-NCI Workshop on Therapeutic Cancer Vaccines

Considerations for Early Phase Clinical Trials Based on Lessons Learned from Phase III

October 27, 2009

Objective and Scope:

FDA and NCI hold a public workshop intended to facilitate the development of safe and effective cancer vaccine by optimizing early phase clinical trials based on lessons learned from completed Phase III studies.  In this workshop, the role of randomized Phase II clinical trials and adaptive study designs was discussed. Furthermore, the workshop emphasized the importance of monitoring immune responses in early phase trials in order to optimize immunological therapies and incorporating pretreatment biomarkers in early phase clinical studies that could predict the effect of specific treatment for patients (predictive biomarkers) in order to identify a population likely to benefit.


Masur Auditorium
Building 10 Clinical Center
National Institutes of Health
Bethesda, Maryland 20892