Clinical Data Management in the United States Where We Have Been and Where We Are Going

Abstract

In the United States, clinical data management (CDM) has been accelerating from a single focus on collecting and preparing clinical trial data for study analysis to a multi-pronged endeavor. This endeavor emphasizes quality data from inception or planning of study design to collection, coding, analysis, reporting, and sharing of all applicable and available data. In this article the influence of legislation and scientific expertise in the collection and analysis of valid, sound data is detailed. FDA requirements as well as academic and technical developments have led to better, more precise and reliable methods in CDM. As such, the perspectives of industry, academia, and non-profits are presented. The role of CDM, at the center of the clinical data explosion, is described, demonstrating how data managers coordinate and build on expertise from all stakeholders. The dependence of biomedical research on CDM and quality data for breakthroughs in diagnostics, drugs, biologics and vaccines is examined. The state of current educational programs is detailed and suggestions are made for new interdisciplinary programs that can provide technical support for all clinical research endeavors. In the article, CDM is viewed through the lens of providing leadership in clinical research and striving to overcome obstacles in communicating the latest technological changes to all stakeholders.