Range Assessment of Simulation Model Parameters for Clinical Trials Phase III: Unsuccessful Clinical Results

Technical Report # USP-MPCS-490-02-03. Student: Brian Melo, BS Pharmacology/Toxicology, 4th year undergraduate. Course: CS 490 - Special Topics in Computer Science for Pharmaceutics (Clinical Trial Simulation). Spring 2002.

In this report the student analyzed a simulation system for clinical trials. The phase III of clinical trial was reviewed to better understand the complete system. From this, decisions on the purpose of the simulation, the level of detail to be used in modeling system, and the boundaries of the system the will be used in the model. The student attempted to compile statistical data on unsuccessful clinical trial. This data can then be use in defining some of the variables and limits of the simulation. Such variables as probability of success or failure by different drug class, different success/failure rates based on the origins of the drug and average duration of a trial before cancellation.
Goals of the project were: a) to learn about the working of phase III clinical trials; b) to find any information concerning Phase III drug studies that fail; c) to collect such data that may be used in future simulation or by future research.
 

Pages 12, Figures 11, References 10.