JSM 2012 Online Program
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Online Program HomeActivity Details
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| 663 * | Thu, 8/2/2012, 10:30 AM - 12:20 PM | CC-Room 22 | |
| Advances in Innovations in Pharmacovigilance and Pro Analysis — Contributed Papers | |||
| Biopharmaceutical Section | |||
| Chair(s): Michelle Ge, Janssen Pharmaceuticals R&D | |||
| 10:35 AM | High-Dimensional Symptom Data in Cancer Trials: Exploring Item Redundancy in the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) — Sandra A. Mitchell, National Cancer Institute ; Amylou C Dueck, Mayo Clinic ; Tito R Mendoza, MD Anderson Cancer Center ; Steven B Clauser, National Cancer Institute ; Bryce B Reeve, The University of North Carolina at Chapel Hill ; Thomas M Atkinson, Memorial Sloan-Kettering Cancer Center ; Antonia V Bennett, Memorial Sloan-Kettering Cancer Center ; Yuelin Li, Memorial Sloan-Kettering Cancer Center ; Jeff A Sloan, Mayo Clinic ; Ethan Basch, Memorial Sloan-Kettering Cancer Center | ||
| 10:50 AM | Multiple Testing in Patient-Reported Symptom Data with Application to the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) — Amylou C Dueck, Mayo Clinic ; Sandra A. Mitchell, National Cancer Institute ; Tito R Mendoza, MD Anderson Cancer Center ; Pamela J Atherton, Mayo Clinic ; Daniel V Satele, Mayo Clinic ; Antonia V Bennett, Memorial Sloan-Kettering Cancer Center ; Yuelin Li, Memorial Sloan-Kettering Cancer Center ; Thomas M Atkinson, Memorial Sloan-Kettering Cancer Center ; Bryce B Reeve, The University of North Carolina at Chapel Hill ; Steven B Clauser, National Cancer Institute ; Jeff A Sloan, Mayo Clinic ; Ethan Basch, Memorial Sloan-Kettering Cancer Center | ||
| 11:05 AM | The Effect of Skip Patterns on the Validity and Reliability of Selected Items from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events — Tito R Mendoza, MD Anderson Cancer Center ; Amylou C Dueck, Mayo Clinic ; Sandra A. Mitchell, National Cancer Institute ; Bryce B Reeve, The University of North Carolina at Chapel Hill ; Yuelin Li, Memorial Sloan-Kettering Cancer Center ; Thomas M Atkinson, Memorial Sloan-Kettering Cancer Center ; Antonia V Bennett, Memorial Sloan-Kettering Cancer Center ; Steven B Clauser, National Cancer Institute ; Ethan Basch, Memorial Sloan-Kettering Cancer Center | ||
| 11:20 AM | Exploratory Scientific Data Analysis — Gary Cline, ICON Clinical Research | ||
| 11:35 AM | Planning for Pharmacovigilance in Phase III Vaccine Trials — Zhen Jiang, FDA/CBER ; Estelle Russek-Cohen, FDA/CBER ; Michael Nguyen, FDA/CBER | ||
| 11:50 AM | Active Surveillance on Medical Observational Databases — Ivan Zorych, Columbia University ; Patrick Ryan, Johnson & Johnson ; Martijn Schuemie, Erasmus Medical Center ; David Madigan, Columbia University | ||
| 12:05 PM | Considerations on Sampling for Medical Chart Review — Haijun Ma, Amgen, Inc. ; Jason Legg, Amgen, Inc. ; Jaekwang Kim, Iowa State University | ||
2012 JSM Online Program Home
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