Seminar/Event Detail

Statistical Issues in Evaluating the Efficacy of Personalized Medicine

Date/Time: 05 November 2012, 2pm - 3pm
Speaker: Dr. Motomi Mori
Speaker Affiliation: Oregon Health & Science University
Venue: JABSOM MEB Rm. 304
For more info: JABSOM BDMC at 692.1814.

Description: With the advance of high-throughput genetics/genomics technology, the concept of personalized medicine is becoming a realistic possibility. In this presentation, we will discuss statistical issues involved in evaluation of the clinical utility of “personalized medicine” using an example of a novel in-vitro screening assay developed by cancer researchers at OHSU. The in-vitro kinase inhibitor assays evaluate sensitivity of primary leukemia cells against a panel of small-molecule kinase inhibitors. It is hypothesized that the assay results can help identify molecularly targeted drugs to which a patient is most likely to respond. Several phase II trial designs were proposed and their operating characteristics were evaluated through simulation. We will present the results of the simulation study and discuss general statistical issues/challenges involved in testing a personalized medicine strategy. These include trial design, patient eligibility, selection of endpoints and control group, randomization, sample size and analysis strategies.

The event is kindly supported by RCMI Multidisciplinary and Translational Research Infrastructure Expansion in Hawaii (RMATRIX: U54MD007584), Bioscience Research Infrastructure Development for Grant Enhancement and Success (BRIDGES: G12MD007602), and IDeA Networks of Biomedical Research Excellence (INBRE: P20GM103466).

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