Objectives
- To appreciate the steps involved in simulating a clinical trial.
- To become familiar with the main features of the Pharsight Trial Simulator.
Introduction
The recognition that traditional methods of drug development often lead to many
clinical trials that contribute little to regulatory approval (Peck 1997) has aroused
interest in exploring other methods. Clinical trial simulation has been advocated
as a way of getting better insight into the real questions that need to be answered
by a clinical trial. The process of model building in itself is a powerful method
of understanding what is known and what remains to be discovered. Simulation of
a clinical trial can provide a data set that will resemble the results of an actual
trial. This can be used for preparing clinical trial databases and rehearsing analysis
plans. Multiple replications of a clinical trial simulation can be used as a form
of meta-analysis to refine clinical trial designs.
The principles of clinical trial simulation are described in:
Methods
- Pharsight Trial Simulator
The Trial Simulator is a tool for creating models and defining clinical trial designs.
It allows the simulation of the trials and offers the ability to analyse the results
and explore the effectiveness of the design.
- Quick Tour
a. Start Pharsight Trial Simulator using the shortcut in the Pharmacometrics Programs folder.
b. Follow the instructions for the Quick Tour (look in the Help menu for Trial Simulator).
c. Try to complete the Quick Tour example.
Assignment
- Describe what information you would need to design a clinical trial that would be
used to test the target concentration strategy for theophylline i.e. is there a
clinically significant difference in peak flow and adverse effects when a target
concentration of 10 or 20 mg/L is chosen to guide dosage.
- Try using Pharsight Trial Simulator to simulate this clinical trial. Attach the
Trial Simulator .std file to show your clinical trial simulation design.
- Write a brief evaluation of your experiences using Pharsight Trial Simulator for:
a. The Quick Tour Example.
b. The Theophylline Target Concentration Strategy Trial.
