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Software Tools Help Manage Clinical Trials

Web-based, analytic software tools help pharmaceutical firms keep patient recruitment on track for clinical trials.
The transparency provided by StudyOptimizer via the Web allows clinical investors and study managers keep abreast of trial sites and countries that are experiencing patient enrollment issues---such as not recruiting enough eligible patients or patients dropping out of studies prematurely. These insights enable clinical managers to address the issues, such as ramping up recruitment efforts at a weaker performing site, or perhaps instead increasing efforts at sites in other countries that are having more success in recruitment.

"If Argentina is not performing because of requirement issues or other reasons, then maybe we can get more patients in China, which is up and running well," said Lancksweert about the ability of study investigators and managers using Optimizer to see how recruitment is going in their region, as well as the ability to use the software to model scenarios for reaching targets -- and testing whether deadlines are "realistic," he said.

Data analysis using StudyOptimizer can be used to improve planning for shipment of drug supplies to the most active trial sites, so that there are no delays in willing and eligible patients receiving the test medications, said Scullion.

The "transparency and engagement" that the software tools offer also fuels competitiveness among clinical investigators to get the job done of recruiting eligible patient, he said. "There's been a significant improvement in unproductive sites," he said. In general, in the pharmaceutical industry, it's estimated about 1/3 of sites responsible for enrolling patients fail to recruit any patients. "A lot of effort is wasted," he said. By providing clinical trial investigators with these Web-based management tools, the spirit of competitiveness is boosted among sites. "Whatever the reason, people are trying harder," he said.

While Lancksweert declined to estimate how much GSK has saved in its clinical trial costs since using StudyOptimizer, he said that in general, clinical trials by pharmaceutical companies cost from $5,000 to $35,000 a day. When reaching patient recruitment goals for clinical trials, "every day is money saved," he said.

DecisionView StudyOptimizer is available via software-as-a-service or on-premise model.