Phase Forward a provider of data management solutions for clinical trials and drug safety, today announced that it has been awarded a contract by the United States Department of Defense (DoD) to support the Food and Drug Administration’s (FDA) plans to access DoD healthcare data for rapid assessment of drug safety issues. The program will be managed by the Pharmacovigilance Center of the Office of the Surgeon General of the Army, which oversees medical benefits programs for Army personnel. Phase Forward will also operate a production server facility to support DoD’s Web-based access to the data, as well as provide general support services including training, application assistance and end user support. FDA’s initiative calls for rapid evaluation of DoD healthcare data on Army active duty personnel, their family members and retirees to determine which potential safety “signals” merit a more thorough investigation through an epidemiological study. “FDA’s data sharing initiative with DoD and other federal partners is an important step forward in drug safety innovation,” said Phase Forward Lincoln Safety Group President Chan Russell. “By partnering with DoD and other healthcare data providers, FDA gains access to a rich and comprehensive set of patient data. We look forward to supporting the DoD and FDA in this important project as part of their efforts to more actively monitor the safety of marketed products.” The contract calls for Phase Forward to provide a data mining capability suitable for use with longitudinal medical records and insurance claims data. To do so, Phase Forward will enhance its Empirica™ software suite to provide a broad new capability for defining a patient “cohort” — a designated patient group followed over a period of time — based on exposure to a particular drug or drugs of interest. The Empirica suite will also analyze the cohort to determine and compare incidences and prevalence of specified safety outcomes with respect to a background or comparator group. Also according to the terms of the contract, Phase Forward will optimize the Empirica software suite to handle more sophisticated definitions of exposure and outcome, including multiple separate exposures for a patient and concomitant exposure to multiple medications. The software suite will be designed to support outcomes involving the presence or absence of multiple symptoms. The contract also calls for expanded capabilities to refine the selection of patients to be considered for inclusion in a full-scale epidemiological study.
