Common Evidence Model for Advanced PHarmacOvigilance REsearch (Cemaphore)

SincePV overproducts of adverse drug reactionsOne of the major challenges that drug safety experts face when conduction pharmacovigilancePVis the many disparate evidence sources they have to contend with when identifyingprioritizingand evaluating PV signalsFewer patients would experience serious harm from drug therapies if PV experts had access to user friendly tools to help them more efficiently searchretrieveevaluateand synthesize drug safety evidence across all relevant sourcesIt is currently very difficult for experts to accurately synthesize evidence across multiple sources because each source has nonintuitive strengths and limitationsuses differing terminologiesand is available in different data formatsThe goal of this Phase I SBIR project is to develop the first pharmacovigilance signal generationprioritizationand validation platform to integrate the major pharmacovigilance evidence sources into a user friendly application based on scalable cloud based web servicesThe project team will use a systematic scientific approach to build a new working prototype for a commercial drug safety research platform called the Common Evidence Model for Advanced PHarmacOvigilance REsearchCemaphoreAimEvaluate a novel automated PV signal prioritization procedure across all the evidence sources in CemaphoreWe will develop and validate three novel algorithms thattogetherutilize the growing number of evidence sources within the Cemaphore to assess PV signal strengthnoveltyand public health impactAimTest the effect on PV signal prioritization of including evidence from predication based semantic indexingPSIof Structured Product LabelingPrior work has focused on PSI of only the indexed scientific literaturei eMEDLINEWe will generate semantic predications using SPLs for all prescription drugsintegrate this novel source into Cemaphoreand then test if the novel source improves PV signal generationAimConduct formative usability testing of a working prototype web UI for PV signal prioritization and validation built with web servicesWe will develop a Cemaphore web UI that provides a single unified view across harmonized evidence sources and publish web services to encourage integration and innovation in the wider eco system of safety PV applicationsThe services will provide a secureperformantcloud hostedREST API to access Cemaphore generated PV signals for hypothesis generationprioritized PV evidence metricsand positive negative controls for empirical calibration of observational study estimatesWe will engage PV experts in think aloud tests of a functional user interface that integrates these services into PV signal investigation workflowsThis SBIR Phase I project will demonstrate the technical merit and feasibility of Cemaphore for advancing active post market risk identification and analysisThe project will contribute to public health by greatly lowering the significant barriers that drug safety professionals face when investigating medication safety signals The goal of this Phase I SBIR project is to develop the first pharmacovigilance signal generationprioritizationand validation platform to integrate the major pharmacovigilance evidence sources into a user friendly application based on scalable cloud based web servicesThe project team will use a systematic scientific approach to build a new working prototype for a commercial drug safety research platform called the Common Evidence Model for Advanced PHarmacOvigilance REsearchCemaphoreThe project will contribute to public health by greatly lowering the significant barriers that drug safety professionals face when investigating medication safety signals