Improving the Efficiency and Ensuring the Quality of Data Assembly for Pharmacometric Analysis

Authors: Grasela TH, Fiedler-Kelly J, Hitchcock D
Conference: PAGE
Keywords: assembly, communications, creation, data, data assembly, dataassembly, dataset, dataset requirements, efficiency, forensic pharmacometrics, forms, informatics, PKPD methodology, process, programming, quality, specifications, team, wiki
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Abstract

Purpose: Better tools and processes can improve the efficiency of data assembly and the quality of analysis-ready datasets for pharmacometric analyses.

Methods: A systematic analysis of unstructured e-mails generated during data assembly was performed to uncover the most frequently discussed issues. These issues were categorized into knowledge domains and used to develop a series of formal programming specification forms.

Results: Issues pertaining to dose were most common. The specification forms were deployed in conjunction with a collaborative website to capture semi-structured communications. Subsequent review of these team communications will enable future refinement and expansion of the specification forms.

Conclusions: The development of these specification forms is anticipated to improve the performance characteristics of data assembly in terms of consistency, reliability, timeliness and quality of the work product.

American Conference on Pharmacometrics (ACoP), Tucson, Arizona, March 2008, and Population Approach Group in Europe (PAGE), St. Petersburg, Russia, June 2009

By Thaddeus H. Grasela, Jill Fiedler-Kelly, Darcy Hitchcock