By Deb Borfiz
February 16, 2010 | A clinical trial intelligence tool newly released by business software giant Oracle appears destined to boost R&D productivity and reshape interactions between industry sponsors and their multitude of partners aiding drug development.
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| Nick Giannasi |
For years now, the key players—pharmaceutical companies, clinical research organizations (CROs), and investigative sites—have navigated their way through clinical studies as special-interest camps with “misaligned objectives,” says Nick Giannasi, vice president of life sciences product strategy in Oracle’s health sciences division. Oracle Clinical Development Analytics, launched in November, is designed to clarify what the targets are and bring visibility to how well they’re being met in real time.The absence of mid-study intelligence has been making rapid, informed decision making difficult and negating many of the benefits of moving from paper to electronic data capture, says Giannasi. Information technology (IT) vendors and consultancies can craft toolkits for the job, but customized solutions are relatively expensive and inconvenient to maintain over the long haul. They don’t even make a lot of sense, now that metrics for measuring performance are largely standardized. Out-of-the-box solutions may be the only plausible means to substantive progress in making clinical development programs more productive and efficient.
Oracle Clinical Development Analytics provides actionable, fact-based insights that are easy to understand and specific to the user’s role within an organization—be it clinical data managers eying completed-versus-expected number of case report forms across a portfolio of studies or clinical monitors identifying sites where training for a particular protocol has yet to happen, says Giannasi. The first version has 45 embedded data management metrics. Sites and partners can be easily compared against a common set of performance yardsticks. The information can be used to take corrective action, minimizing cost and time losses, as well as establish preferred partnerships with top performers.
Data transparency enhances trust between and among sponsors, CROs, and sites while helping to eliminate “adversarial discussions,” says Giannasi. That’s a soft but important product benefit, given the often fractious relationship between the three parties. Project managers and clinical monitors empowered with information to do their jobs better should also be easier to retain.
The potential dividends for study monitors are particularly noteworthy. With Clinical Development Analytics, they can use key site performance metrics to help balance their workload and do more targeted traveling, says Giannasi. The application can be loaded on Apple iPhones, which outpace Blackberries in popularity among monitors. Plug-ins will be easy to create for other mobile devices moving forward, he adds, since the software is built on an open IT platform.
Similarly, minimal IT know-how is required for users to add company-specific performance metrics or customize and publish their own dashboards with the software’s drag-and-drop interface, says Giannasi.
Oracle Clinical Development Analytics is currently being evaluated by several large sponsors and CROs, says Giannasi. Its major strength is the underlying brand. Oracle is a big player in the software space and the market leader, worldwide across industries, in the business intelligence niche. It is well positioned to access data from its other IT products and has more than 50,000 users of its clinical trial management system from which it can learn and mine strategic development partners. The demand for clinical development intelligence is also expected to escalate in response to growing interest in adaptive trial design, translational medicine, and use of electronic health records in longitudinal and comparative effectiveness studies.
MRI manufacturers using analytic software to help service engineers prioritize visits to imaging centers may be suggestive of the type of productivity gains the new Oracle solution could deliver. Using that as a benchmark, productivity gains among monitors using Clinical Development Analytics could be in the 10%-25% range with a positive ripple effect on site output, says Giannasi. Over the next six to 18 months, Oracle plans to build case studies demonstrating the product’s contribution to reducing overall drug development cycle time.
Ultimately, the software may help lessen the number of monitors and sites needed per study, as well as reduce the need for the support of external patient recruitment companies, says Giannasi. “At the moment, enrollment is more art than science.”