Event Summary:
A one-day workshop organized by the Center for Interdisciplinary Research and
Consulting at the University of Maryland, Baltimore County (UMBC), and the
Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.
Registration is now closed
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Organizing Committee:
Yi Huang (UMBC)
Nagaraj Neerchal (UMBC)
Bimal Sinha (UMBC)
Tze Lai (Stanford)
Phillip Lavori (Stanford)
Ying Lu (Stanford)
Jie Chen (Novartis)
Joseph Heyse (Merck)
For more information:
Please contact Dr. Yi Huang, Department of Mathematics and
Statistics, University of Maryland Baltimore County (UMBC),
1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.
For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.
Participant Information
Keaven Anderson from Merck Research Laboratories.
Paper: A Graphical Approach to Multiplicity in Late Stage Oncology Trials at Merck
We consider Phase 3 studies where there is interest in treatment effect in an overall population and one or more identified biomarker-specified subgroups. Hypotheses for multiple endpoints such as progression free survival (PFS) and overall survival (OS) are of interest. Finally, a group sequential approach with 1 or more interim analyses is required. There is generally one endpoint and population that drives timing for each analysis. In this context, we consider extending the work of Maurer and Bretz (2013, SBR) to use sequential p-values with graphical multiplicity procedures to provide strong Type I error control. An example for an oncology trial will be provided.