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Part of the HDFCCC Physician Scientist Program in Clinical Oncology's Concept to Completion, Stategies for Successful Clinical Trials Seminar Series.

Speakers:

• Pamula Munster, MD - Professor, Dept. of Medicine (Hematology/Oncology); Director, Early Phase Clinical Trials Unit, Co-leader of the Center for BRCA Research, and Co-Leader, Molecular Oncology Program, UCSF Helen Diller Family Comprehensive Cancer Center
• Ann Lazar, PhD, MS - Professor, Preventative & Restorative Dental Science

Learning Objectives:

Dr. Lazar:

• Describe the steps needed to conduct a RCT and explain why it is a rigorous scientific method.
• Understand the strengths and weaknesses of experimental study designs.
• Discuss the purpose of sample size calculations, controls, blinding and randomization in research designs.

Dr. Munster:

• Describe the difference between objectives vs endpoints
• Explain different types of innovative clinical trial design (e.g., phase 0, biomarker-driven, and adaptive designs)
• Discuss tips of the trade- accommodating a limited budget/sample size, the role of an interim analysis (futility, safety, efficacy), use of safety lead-ins
• Summarize tips for reviewing clinical data and pitfalls to avoid