Perspectives on the Adoption of Electronic Resources for Use in Clinical Trials

Perspectives on the Adoption of Electronic Resources for Use in Clinical Trials

Maricarmen D. Planas-Silva (Pennsylvania State University - Harrisburg, USA) and Rhoda C. Joseph (Pennsylvania State University - Harrisburg, USA)
DOI: 10.4018/978-1-60960-183-6.ch002
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Abstract

Clinical trials are specific medical studies that use human subjects for the advancement of medicine. Evidence-based medicine requires the use of clinical trials to evaluate new treatments, devices, drugs, and modalities for the prevention and treatment of diseases. Clinical trials have not been particularly aggressive in their adoption of information technology (IT). In this analysis, we examine the impact of electronic resources on the execution and management of clinical trials. Further, we present a theoretical model showing the main areas of clinical trials that can be directly impacted by the adoption of electronic resources. The four areas identified are recruitment, data collection, process data management, and information dissemination.
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Overview Of Clinical Trials In The United States

In order to bring a new drug to the market a pharmaceutical company needs to perform many clinical trials and spend millions of dollars. Further, clinical trials are done to determine the safety of a drug and compare effectiveness of different doses of the drug.

Clinical trials for testing a new treatment typically occur in three or four stages (typically listed as stages I through IV) (Houlton, 2004) and can range is cost from $500 million to more than $2 billion (Adams and Brantner, 2006). To understand how IT can impact or has impacted clinical trials, we first consider the different aspects of a typical clinical trial in cancer research. A novel cancer drug is first tested in phase I and phase II trials. If phase I trials and phase II trials are effective without safety issues, a phase III clinical trial is proposed and performed. Phase IV trials are conducted after FDA approval (i.e. post-marketing).

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