gsDesign Explorer to Optimize Merck's Clinical Trial Process

By CIOReview | Monday, April 7, 2014

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FREMONT, CA: Today, most of the pharmaceutical firms face hurdles in the clinical trial drug development process. They often waste money and time by tirelessly analyzing massive amounts of mission critical data. Aimed at dealing with these kinds of obstacles, Merck, a pharmaceutical firm, has started implementing Revolution Analytics’ gsDesign Explorer graphical user interface (GUI).

This solution is based on gsDesign, a group sequential design package for the R language. It provides clinical trial design with interim analyses to evaluate efficacy and control false positive and negative error. Interim analyses offer opportunities for early stopping of trials if, for example, the new treatment is demonstrably better than the standard treatment or clearly inferior.

Keaven Anderson, Executive Director of Late Stage Biostatistics, Merck says, “gsDesign Explorer significantly reduces the time of data analysis required in sequential drug testing. Recently, we had a trial at Merck that we couldn’t have done without gsDesign Explorer. This project allows promising new drugs to get to market faster at less cost, thus enhancing their potential to improve patient outcomes and save lives.”

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gsDesign Explorer allows data analysts to instantly create, compare, and produce graphical and textual summaries of multiple group sequential clinical trial designs. This solution enables users to focus on model parameters and clinical implications without being burdened by technical details.

Further, this GUI is integrated with R (an open source software tool), so that a user can go back into the GUI and further customize it to enhance graphics.

“We use R for adaptive designs frequently because it’s the fastest tool to explore designs that interest us. Off- the-shelf software, gives you off-the-shelf options. Those are a good first order approximation, but if you really want to nail down a design, R is going to be the fastest way to do that,” Keaven adds.