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
Olga Marchenko from Quintiles.
Paper: Statistical challenges and opportunities in the era of personalized medicine and targeted therapy
While the concept of personalized medicine is not new, recent advances in science and technology set in motion a transformation from an idea to a practice. Finding the right drug for the right patient at the right dose and time is the major objective of personalized medicine. The US FDA approved multiple targeted therapies for patients with various diseases and many more are being studied in clinical trials either alone or in combination with other treatments. Statistical methods allowing to screen and validate biomarkers, assess biomarker’s cut-offs, identify subgroups, and enrich population based on a biomarker or several biomarkers are of great interest and grow in demand. In this presentation, an overview of several recently proposed methods and designs to select “the right drug for the right patient” and “the right patient for the right drug” will be presented and discussed. Statistical and operational challenges together with opportunities for new development will be outlined using case studies.