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Session 8: Novel Statistical Methods in Oncology Studies
Session Chair(s)
Jeff Maca, PhD
Senior Director, Biostatistics; Advisory Services Analytics, Quintiles, United States
With the development novel targeted agents and immunotherapy, the clinical trial designs and the statistical considerations that can achieve the objectives to demonstrate the treatment effects are critical. The advances in science provide an opportunity to target the population that benefits most with least risk. This has led to development of adaptive enrichment design strategies with more complex trial designs and a comprehensive trial network that can answer multiple objectives with multiple outcomes. Such protocols need careful advance planning with often little or minimal prior information and process has to be adaptive to fast changing environment with the development of novel therapies and drug approvals. In this session we will discuss features of such novel designs.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Explain statistical issues arising in oncology studies
- Understand the impact of biomarkers and their use in oncology studies
- Discuss advantages and disadvantages of Umbrella or basket trials
Speaker(s)
Rajeshwari Sridhara, PhD
Senior Biostatistician Consultant, Oncology Center of Excellence, FDA, FDA, United States
Session Co-Chair
Keaven Anderson, PhD
Scientific AVP, Methodology Research, Merck & Co., Inc., , United States
Speaker
Mary Redman, PhD
Lead Biostatistician, SWOG Lung Committee/LungMap, Assoc. Member, Clin Research, Fred Hutchinson Cancer Research Center, United States
Speaker
Kun He, PhD
Mathematical Statistician, Division of Biometrics V, OB/CDER/FDA, United States
Speaker
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