Phase Forward, the US company that specialises in data management solutions for clinical trials and drug safety, has won a contract from the US Department of Defense to support the data-sharing initiative announced last year by the DoD and the Food and Drug Administration.
In August 2007 the DoD and the FDA formed a partnership under which they agreed to share data and expertise related to the review and use of FDA-regulated drugs, biologics and medical devices.
Operating as part of the FDA’s Sentinel initiative to build a national, integrated, electronic system for monitoring medical product safety, the partnership aims at rapid assessment of DoD healthcare data on Army active duty personnel, their families and retirees, to determine whether product safety trends merit further investigation through epidemiological studies.
The programme Phase Forward is supporting will be managed by the Pharmacovigilance Center of the Army’s Office of the Surgeon General, which oversees medical benefits arrangements for Army personnel. Phase Forward will operate a production server facility to support the DoD’s web-based access to data under its partnership with the FDA as well as providing general support services including training and application assistance.
Phase Forward will also supply data mining capability suitable for use with longitudinal medical records and insurance claims data. This will involve enhancing the company’s Empirica software suite to develop a broad new capability for defining patient cohorts based on exposure to a particular drug or drugs of interest. The Empirica suite will also analyse the cohort to determine and compare the incidence and prevalence of specified safety outcomes with respect to background or comparator groups.
Another element of the contract is optimising the Empirica software suite to handle more sophisticated definitions of exposure and outcome, including multiple separate exposures per patient and concomitant exposure to multiple medications. Phase Forward will also expand its capability to refine the selection of patients who may be considered for inclusion in a full-scale epidemiological study.
