Therapeutic vaccines: advances in understanding of appropriate patient selection and trial design

In Regulation and Policy by Freya SmaleLeave a Comment

download, patient selection, trial design

Dr James Gulley, Director, Clinical Trials Group & Deputy Chief, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health joined us at the World Vaccine Congress Washington to lead the discussion of appropriate patient selection and trial design in the production of therapeutic vaccines.  His conclusions included:

• Appropriate endpoints
     – Kinetics of clinical response following immune response may be initially subtle or delayed, but potentially long-lasting with growing cumulative benefit
     – Immune response is dynamic – broader, better response over time.
     – OS (for vaccine alone)
     – Urgent need for biomarkers predictive of clinical benefit in immunotherapy studies
• Appropriate patient populations – Earlier is better

Why not download the full presentation and find out more about patient selection and trial design!

Download the full presentation here!

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