SCS Capabilities — Applied Modeling and Simulation Training Curriculum
Special Modeling and Simulation Topics
Use of Preclinical Data
(half-day course, computer-based lab)
This course illustrates M&S principles that can be applied to enhance
clinical and preclinical learning and make robust extrapolations from animals
to man. Different M&S strategies and goals are illustrated and applied
to different situations depending on the amount of prior information that
is available. M&S is used to provide predictions for first
human dose and place bounds on the risk of uninformative or “no findings”
trials.
Use of Literature Data
(half-day course, computer-based lab)
This course reviews available methodologies that use subject-level data
and summary data from literature. Topics covered include sources of data
and efficiently incorporating literature data in scientific modeling and
simulation.
Binary and Categorical Data Analysis
(1 day course, computer-based lab)
This course explores special modeling and simulation techniques using
binary and categorical response data including linear probability response
models, data transformations, logistic models, responder data, and the
use of ordered categorical data for clinical scales such as pain
relief and quality of life.
M&S of Time-to-Event Data
(1 to 1.5 days course, computer-based lab)
This course introduces population PK/PD modeling of time-to-event data
and simulation from time-to-event models. During the first session (approximately
3 hours), basic principles such as hazard and survival will be discussed.
The second part of the course (7 hours) is allocated to specific issues of time-to-event analysis: development of simple constant hazard models, multivariate response models, time-varying hazard models, model diagnostics, survival analysis in oncology, recurrent time to event, modeling of count data, and simulation aspects of time-to-event data.