By Aaron Krol

January 28, 2016 | The FDA has entered a partnership with Commonwealth Informatics, a healthcare analytics company based in Waltham, Mass., to create a platform for investigating drug safety concerns. The aim of the two-year Research Collaboration Agreement, which does not involve funding, is to provide the FDA with a program it can use to review both new drug applications, and postmarket surveillance studies.

Commonwealth has already built the core platform, called Commonwealth Clinical Data Analytics (CCDA), as part of a collaboration with the Army Pharmacovigilance Center to monitor drug side effects within the Military Health System, which keeps records on over 15 million patients. CCDA acts as a search and visualization layer on top of this type of massive clinical database; users can pull up patients who fit certain search criteria, then view their medical histories on a timeline.

This ability to look at drugs and adverse events in the context of a patient’s larger medical history is important in drug safety studies, where it’s often hard to tell if rare events are genuine side effects, or just noise in the data. “If you’re looking for some pattern, and you’ve found some set of patients that seem to fit the pattern, you now would like to look at that more closely,” says Chan Russell, System Architect at Commonwealth. “You might think, ‘This looked like an adverse event from this drug, but here are all the other drugs this patient was on, and some of them are correlated with that kind of adverse event.’”

Russell, like several other members of Commonwealth, has already worked with the FDA on drug safety projects as a former member of Oracle, whose Empirica platform is used at the agency to search for early warning signs of unknown side effects. CCDA, however, would mainly be used downstream of this kind of automated monitoring, to confirm suspected cases of a treatment causing an adverse event.

CCDA is already attuned to healthcare data, so it can work with datasets from a clinical trial, or medical records collected during postmarket surveillance. “If you’re working with clinical data, you want your tool to know some things out of the box,” says Geoffrey Gordon, Commonwealth’s founder and president. “It knows what a patient is, what a drug is, what an adverse event is.”

“These datasets are really big,” he adds. “The drug prescription table that we often deal with is 2.5 billion rows. There aren’t a lot of analysis programs that can handle that.”

While CCDA is already in a working beta, the FDA partnership will lead to new features and tweaks to the platform’s capabilities. For instance, the agency may want to interface between CCDA and internally developed tools, like the openFDA platform that collects together and structures data from publicly available adverse event reports. The FDA has also requested that CCDA be linked to the programming languages R and SAS, so data scientists in the agency can more easily build custom workflows.

The biggest priority for CCDA, according to Gordon and Russell, is for physicians to design their own analyses without intervention by programmers. Studies of drug safety can involve complex parameters, as medical professionals search for patients with specific mixes of symptoms, medications, and additional risk factors. “They may take a very big database of spontaneous reports that have come in, from patients or doctors or sponsors, and they want to do signal detection,” says Russell. “They’re looking for whether something has changed, or do the adverse events seem different from other drugs in the class, or has there been a shift in the population being prescribed for?” For physicians to fully trust the results, they need to be able to audit an analysis like this themselves, confirming that they’ve brought up the right patient records for closer inspection.

Commonwealth is also planning a commercial launch of CCDA later this year, for clients in the pharmaceutical industry and large healthcare organizations. While early demonstrations of the software have focused on adverse events, Russell suggests it could also be used to give providers more oversight into their prescription patterns, or other practices that affect the cost of care.

“Our own center of gravity has been around drug safety,” he says, “but it’s a good fit for efficacy and outcomes too.”