A Measurement Error Model and Neuroimaging Trials

Chunming Li
Pfizer, Inc.
ABSTRACT:
In the presentation, I will begin with a discussion on some common brain imaging modalities in clinical studies. I will share the clinical study objectives and issues using imaging biomarkers. However, the focus will be on a measurement error model and its application to an Alzheimer's magnetic resonance imaging (MRI) trial. The statistical methodology, associated sample size estimation and simulations will be discussed and presented.

Statistics in Drug R&D

Kongming Wang
Wyeth, Inc.
ABSTRACT:
The goal of drug research and development (R&D) is to deliver safe, effective and affordable medicine for patients. Drug R&D is a complicated process. Statistical support is essential to every step of the process (biomarker research, adaptive design, integrating economics into the development strategy, decision making, simulations, just to name a few), as evidenced by the increasing number of statisticians working in the pharmaceutical industry. This short presentation reviews statisticians!/ involvement in the process of conducting a phase 2 clinical trial.