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Some Innovative Approaches to Handling Missing Data Problems in Clinical Trials
Program Code:
414
Date:
Thursday, June 27, 2013
Time:
9:00 AM to 10:30 AM
EST
CHAIR
:
Peiling Yang, PhD (SCHAGY), Team Lead, Division of Biometrics I, Office of Biostatistics, OTS, CDER, FDA, United States
SPEAKER
(S):
Jinglin Zhong, PhD (SPKAGY), Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA, United States
Sonia Davis,
DrPH (SPKSUP), Director of the Collaborative Studies Coordinating Center, Dept of Biostatistics,
University of North Carolina, United States
Sonia Davis became Director of the Collaborative Studies Coordinating Center and Professor of the Practice at the UNC Dept of Biostatistics in 2012. Formerly she was Senior Director of Biostatistics at Quintiles, Inc. Her research interests include clinical trial design and analysis of missing data.
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Mat Davis,
MS (SPKNON), Project Statistician,
Theorem Clinical Research, United States
Mat Davis is a statistician at Theorem Clinical Research. His primary areas of research are missing data in clinical trials and measures of agreement and reliability. He has experience in a number of therapeutic areas including medical diagnostics, Alzheimer's disease and rheumatoid arthritis.
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Description
In this session, innovative alternative designs will be proposed that may be applicable to trials in certain disease areas to mitigate missing data problems. With regard to sophisticated analyses, such as multiple imputation and pattern mixture model, which require simulating data sets to impute missing values, an illustration will be given as to how to pre-specify the computer algorithms and capture simulated data values in ADaM to enhance the traceability and reproducibility.