The Defense Department has awarded a contract to Phase Forward Inc. to provide data-mining services for a joint project with the Food and Drug Administration and the Veterans Affairs Department to monitor the safety of new drugs.
The project will support FDA's Sentinel initiative for the rapid assessment of drug safety issues. The Pharmacovigilance Center (PVC) of the Army's Office of the Surgeon General is managing the contract.
The Sentinel project seeks to evaluate health care data from active-duty Army personnel, their family members and retirees to determine which potential safety signals merit a more thorough investigation through an epidemiological study.
The contract calls for Phase Forward to provide data-mining services for medical records and insurance claims information. The firm specializes in integrated data management for clinical trials and drug safety evaluations.
As part of the arrangement, the company will enhance its Empirica software to handle more sophisticated definitions of exposures and outcomes and to refine the process for selecting patients for epidemiological studies.
Phase Forward will also operate a production server facility to support DOD's Web-based access to the data and provide training, application assistance and user support.
"The concept is to detect early things that can go wrong with medical products and to ensure their safe use by the force," said PVC director Col. Trinka Coster.
The contract funds further development of Phase Forward's software tools, which will be tested after development is complete, Coster added.
PVC's support for Sentinel currently focuses on identifying potential adverse effects from drugs and vaccines, but center officials plan to eventually expand the program to include adverse effects from medical devices.
"We engage in processes called signal detection and rapid analysis," Coster said. "We use analytic tools to detect adverse events. If we consider a signal to be significant, we then go through processes called signal verification and strengthening to make sure what we have identified are true signals."
The PVC program analyzes data imported from the military's electronic medical record system, the Central Data Repository and the Pharmacy Data Transaction Service.