The collection and analysis of drug concentration data collected during clinical trials is growing in popularity as a mechanism for explaining variability in patient outcomes. This paper describes an automated drug concentration screening and quality assurance program to monitor the acquisition of drug dosing information and concentration time data during clinical trials. This program serves to expedite the data cleaning process, allows for monitoring of possible concentration-related safety events, screens for drug-drug interactions during the execution of clinical trials, and provides the ability to produce interim, blinded reports to the sponsor and the data safety monitoring board. The goal of this paper is to describe the operation of the program as it has been used in practice and to highlight its benefits in the development program for delavirdine mesylate, a nonnucleoside reverse transcriptase inhibitor recently approved for the treatment of HIV infection.
By, Thaddeus H Grasela, Antal EJ, Jill Fiedler-Kelly, Foit DJ, Barth B, Knuth DW, Carel BJ, Cox SR