PATIENT RECRUITMENT

By Deborah Borfitz

Nov. 3, 2008 | DecisionView has just released the latest version of StudyOptimizer, Web-based clinical trial software that helps study managers more intelligently craft recruitment and enrollment plans, spot problems early, and test potential solutions before taking corrective action. It quenches the industry’s “thirst for predictable performance” and on-time study completions, says CEO Steve Andrade.

Enrollment problems currently delay 95 percent of all trials because of the difficulty of manually aggregating data from disparate sources to track site performance and predicting the impact of various possible course corrections on enrollment timelines, says Andrade. StudyOptimizer enables study managers to test assumptions and fine-tune recruitment and enrollment plans before they’re initiated, and then monitor actual performance – site by site, region by region, or country by country – making needed adjustments to the plan in real time as a study progresses. The result, more often than not, is that a trial behind schedule finishes on time.

Steve Andrade

“I’ve spent more than 20 years in the life sciences and technology industry,” says Andrade, “and what’s striking to me is that study sponsors are still using rudimentary tools [typically, a customized Excel spreadsheet] to manage parts of the broader clinical process. In talking to [pharmaceutical companies], it has also been enlightening to understand what they’re really looking for is not just automation of the recruitment planning process and transparency, but visibility into projected performance and an ability to adjust performance earlier in the process.”

StudyOptimizer 4.0 is “faster and more flexible” than the previous version and has enhanced visuals, navigation, and security features, says Andrade. A new “intelligent task pane” allows users to understand and execute the steps needed to complete a recruitment plan. User interface elements can also now be hidden or resized. The application’s new analytic engine performs complex calculations faster and delivers analytic views into operational data and a new enterprise-class J2EE application server provides higher “reliability, scalability, availability, and performance.”

DecisionView’s established base of customers, including GlaxoSmithKline (GSK) and two other top-ten biopharmaceutical companies, have yet to make the switch from version 3.5 that was launched late last year. But the company reports several new customers adopting StudyOptimizer 4.0. The original application was launched in early 2006.

According to technology research firm Gartner (Stamford, CT), StudyOptimizer has helped companies finish 50 percent more clinical trials on time and reach recruitment target milestones 20 percent more often. GSK independently reports that it has doubled the frequency with which trials are completed on time. “StudyOptimizer has enabled our teams to work in a more collaborative style to create robust plans grounded on empirically justified assumptions, and to streamline decision making by more effectively communicating trial progress to a dispersed study team and participating research sites,” says Alex Lancksweert, director of business performance analytics at GSK.

Consulting firm Hobson & Company (Westwood, MA) collaborated with companies in the pharmaceutical industry and DecisionView to develop a free return-on-investment model that helps pharmaceutical companies quantify the cost of enrollment-related trial delays and the contribution StudyOptimizer can make in alleviating them. The “hard dollar cost” of doing nothing is self-reported by various companies to be a million dollars or more monthly, says Andrade.

The business benefits have been documented in the areas of faster cycle times, reductions in clinical recruitment costs, and increases in productivity. “Costs are taken out of the equation because StudyOptimizer helps trials recruit to plan,” says Andrade. As a result of automation, visibility into predicted performance, and scenario modeling capabilities, smarter decision-making is being enabled and companies using the tool find they can “do more with less.” Recruitment and enrollment cycle times also speed up.

Unlike the vast majority of e-clinical technologies, which can take from six months to more than two years to implement, StudyOptimizer can be fully deployed in a customer’s environment within 90 days, says Andrade. A hosted model is also available.

In the future, DecisionView plans to extend its Performance Optimization platform into other clinical development business processes, including clinical supply management, site selection and management, and clinical budget forecasting, says Andrade.

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