An Exploratory Evaluation Framework for e-Clinical Data Management Performance
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An Exploratory Evaluation Framework for e-Clinical Data Management Performance
Drug Information Journal 46(5) 555-564 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512452119 http://dij.sagepub.com
HyunJu Lee, PhD1, and Sangwon Lee, PhD2
Abstract Electronic data management is becoming important to reduce the overall cost and run-time of clinical trials with enhanced data quality. It is also imperative to meet regulated guidelines for the overall quality and safety of electronic clinical trials. The purpose of this paper is to develop an exploratory performance evaluation framework for e-clinical data management. This study performs a Delphi survey for 3 iterative rounds to develop an exploratory framework based on key informants’ knowledge. Four key metrics in the areas of infrastructure, intellectual preparation, study implementation, and study completion covering major aspects of clinical trial processes are proposed. Performance measures evaluate the extent of regulation compliance, data quality, cost, and efficiency of the electronic data management process. They also provide measurement indicators for each evaluation item. Based on the key metrics, the performance evaluation framework is developed in three major areas involved in clinical data management—clinical site, monitoring, and data coordinating center. From this initial attempt to evaluate the extent of electronic data management in clinical trials by a Delphi survey, further empirical studies are planned and recommended. Keywords clinical trials, data management, electronic data capture system, performance metrics
1. Background and Purpose In the past decade, the clinical trials market has grown in practice of evidence-based medicine. Along with this, there is a trend toward increasing investment in clinical research and reinforcement of system development. As the scope of clinical trials extends to a global setting and more safety issues are required, more cost-effective approaches are necessary. The utilization of electronic data management systems is the reason for this. Research1 shows that electronically integrated data management can lead to high performance in the clinical trials industry along with its evolvement over time. Electronic data management systems play a particularly important role in their support by highly efficient and cost-effective data management with enhanced data quality.2-4 In reality, the Korean clinical trial market does not deeply recognize the important role of electronic data management. This is supported by the fact that there have been few academic studies related to electronic data management among studies on clinical trials while relatively low attention has been paid to data management in practical fields. Although the quality of clinical trials is considered to be critical to the successful achievement of trials, there has been little consideration of the
influence of data management on the quality of clinical trials. Electronic data management is still
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