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Abstract
Clinical trial conduct today requires improvements in efficiency, accuracy and subject safety. These benefits are available as the industry makes clinical trial process changes through Webbased technology.
Keywords: clinical trials, EDC, Web-based technology, process change, site investigators, subject safety
INTRODUCTION
The clinical trials industry provides the human clinical research process for new product development in the pharmaceutical, biotechnology and medical device industries. According to Forrester, the clinical trials industry was a US$50bn industry in 2000, experiencing double-digit growth since 1995. The growth of this industry is expected to continue at a rapid rate owing to the increased pace of new drug compound and genomic discoveries. Figure 1 provides information on the development life cycle of a new drug compound, illustrating the timeline of discovery, research and submission. Issues today include increased development creating a bottleneck at clinical research, and the need to reduce the research cycle. A major problem with the current development cycle is the limited time a sponsor maintains a patent-protected revenue stream from an approved product. A major area of concern is the ability of the clinical trials industry to keep pace with the discovery growth.
Many industries have transformed their business practices over the past 20 years because of technology enhancements. Enhancements included larger and much more powerful computers, the proliferation of smaller, yet powerful and flexible personal computers, and the development of business software taking advantage of these gains in computing power and flexibility. One industry where the technology gains have not produced as much as expected is the clinical trials industry. A major reason for the lesser gains is the heavy reliance on paper-- driven processes required to meet regulatory requirements for clinical research. The end result is that clinical research today lags behind most industries in taking advantage of technology gains. To become more efficient and to meet the growing clinical research demand described above, the industry must take advantage of better technology-driven solutions becoming available now.
eClinical Trials (eCT) refers to the result from a transformation of the clinical trials industry from a slow, inefficient paper-driven industry to a rapid deployment, real-time conduct, efficient industry driven by technology-enabled clinical processes.
The goal of this paper is to address the issues inherent in...