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Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs

Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs. Richard Simon, D.Sc. National Cancer Institute linus.nci.nih.gov/brb. Objectives of Phase I Trials. Develop dose/schedule Determine whether the drug inhibits the targeted pathway. Dose/Schedule.

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467 views • 32 slides

Clinical Trial Design Considerations for Therapeutic Cancer Vaccines

Clinical Trial Design Considerations for Therapeutic Cancer Vaccines. Richard Simon, D.Sc. Chief, Biometric Research Branch, NCI http://linus.nci.nih.gov/brb. Why focus on early clinical development?. Principles for phase III trials apply equally to vaccines Randomized control group

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830 views • 24 slides

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Simon r et al - PowerPoint PPT Presentation

Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs

Clinical Trial Design Considerations for Therapeutic Cancer Vaccines