White Paper

Simplifying The Analysis Of Genomic Data In Clinical Trials

Source: Comprehend Systems, Inc.

By Comprehend Systems

The completion of the Human Genome Project in 2003 launched a revolution in drug development and medical therapies in the pharmaceutical and biotechnology industries. The explosive growth of genomic-based drug research continues to drive improvements in clinical trials and significant opportunities in personalized medicine and orphan drug research. Genomic sequencing has rapidly become a major part of translational research, with a dramatic increase in the number of clinical trials using this technology to understand and improve human health. Currently, according to ClinicalTrials.gov, there are 59 clinical trials using genomics data.

However, this promising research generates large amounts of data, from clinical test results to microarray gene expression profiles. The expanding scope and complexity of these datasets pose challenges in data management and analysis. The concept of efficient, flexible, SaaS (software-­‐as-­‐a-­‐service)-­‐based, virtual on-­‐demand data warehouses with advanced visualization-­‐based data discovery capabilities holds the promise of integrating clinical, operational and safety data with genomics data for analysis during the course of clinical trials. This paper addresses the impact of genomics on clinical trials, the challenges it presents for data management, and the rationale for a virtual, on-­‐ demand data warehouse solution.