SCS Capabilities — Applied Modeling and Simulation Training Curriculum
Computer Assisted Trial Design (CATD)
Overview of CATD
(1 day course, lecture-based)
This course provides an overview of modeling and simulation in clinical
and pre-clinical drug development with emphasis on describing basic principles,
theory, and value of CATD in drug development. This course is suitable
for a wide range of attendees including pre-clinical and clinical development
scientists, as well as project team directors and managers interested in
understanding the value and use of CATD in drug development.
Basic CATD
(2 day course, computer-based lab)
This course teaches the execution of CATD problems on the computer platform,
including implementation of clinical trial designs, drug and disease models,
trial protocols, drop out and compliance models, and preliminary display
and manipulation of simulation results. The module provides the participant
with a basic understanding of Pharsight® Trial Simulator™ and the
ability to perform and execute simulations using Trial Simulator.
Efficient Trial Simulation
(1 day course, computer-based lab)
This course explores simulation design and coding methods to facilitate
run-time efficiency. Simulation skills taught include developing succinct
models, interfacing Pharsight Trial Simulator efficiently with external
analysis packages, and making appropriate simplifying assumptions. The
module provides efficient methods for exploring and understanding the role
of uncertainty in simulation models.
CATD Statistics, Power and Trial Design Fundamentals
(1 day course, computer-based lab)
This course examines methods to impute the distribution of trial outcomes
under different design/assumption scenarios and to compare risk/performance
tradeoffs of trial designs to meet trial objectives. A survey of alternative
trial designs provides insight into their ability to achieve primary objectives
efficiently while enhancing learning and managing risk appropriately.
Understanding Dose-Response
(half-day course, computer-based lab)
This course identifies the appropriate trial design and doses for robust,
efficient confirmatory trials. An exploration is provided of appropriate
dose selections, the number of treatment arms, and trial size to meet trial
objectives.
Adaptive Designs
(half-day course, computer-based lab)
This course presents the use of adaptive designs. Participants learn how
to design informative trials and manage risk for a range of problems when
high uncertainty remains a dominant feature of a development program.