Photography: Comstock, EyeWire Illustration: Paul A. Belci
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Finding ways to streamline the clinical trial process, i.e., lower costs and speed promising new treatments to market—all
while ensuring patient and consumer safety—is a top priority of pharmaceutical manufacturers, the FDA, and third- party technology
developers.
Automating these processes with technology has been viewed as the way to make clinical trials less time consuming, more cost
effective, and more efficient. The fact is that many trials fail; and the cost of such failures, in terms of time and money
invested, is staggering. The rate of new drug approvals has been steadily declining. Fewer and fewer new treatments are reaching
the people who need them; it takes longer and longer to complete a clinical trial, and costs have been rising significantly.
According to CDISC, EDC solutions captured 13% of total clinical trials initiated in 2004. Sponsors responding to the CDISC
survey also indicated that they expect only 60% to 70% of all clinical trials to be appropriate for technology usage.1
The reasons are varied and complex. They can range from the current legal and political climate, market forces, and global
economic issues to technology shortcomings and simple human nature. Many of these issues are beyond the control of any single
organization or political entity. One issue that is controllable is how to make the best use of your clinical trial technology.
Simplifying, streamlining, and integrating the technology used in the clinical trial process will help make it less costly
and time consuming, thus removing a major obstacle to new research incentives. Improving how technology is used and opening
up communication across technology platforms will also enhance the process, creating greater efficiencies and fewer errors.
Figure 1. Integrating the Enterprise.
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The FDA has responded to the problem of slowed development with its Critical Path Initiative (CPI). By encouraging cooperation
between government, research institutions, and the pharmaceutical industry, the CPI attempts to streamline the clinical trial
process by mandating the standardization of clinical practices, standards, and definitions, and by developing new and better
trial technologies. In fact, among all of the issues cited by the FDA in its CPI document, technology is rightly identified
as the most promising in terms of effecting a rapid and broadly acceptable solution. However, mandating a technology solution
is a small part of the process. Many technology tools have been produced over the past few years to automate the clinical
trial process, but they do not all speak to each other.
How did we get here?
Before computerization, the tasks of collecting, organizing, recording, and analyzing clinical trial data were handled manually.
The process was slow, tedious, and prone to error.
The promised benefits of automation appeared here and there, in small isolated pockets, but never broadly enough to be felt
across the entire industry.
Due to the sheer magnitude of diversity and complexity in the clinical trial industry, wide use of these new technologies
is still pending. At present, many pharmaceutical, research, and clinical trial organizations still find themselves using
methods from the last century—paper-based manual systems —to perform tasks that would be more efficiently completed using
technology.
Another part of the problem is that across the industry, the technology infrastructure is hopelessly diverse, incompatible,
and/or simply out of date. This is a natural result of organizational infrastructure lagging behind the rapid pace of scientific
and technological development.
In spite of the complexity and diversity of the process and the industry, there is a way to integrate the clinical enterprise,
helping organizations to make the best use of their technology and get return on their investment.
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