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The Empirica™ Signal application is a web-based analysis environment for generating statistical scores for combinations of drugs and events in a drug safety database, and for detecting signals (unexpected associations of drugs and events). The source data may be public data, such as the data in the Adverse Event Reporting System (AERS); Vaccine Adverse Event Reporting System (VAERS); WHO Vigibase ADR (Adverse Drug Reaction) databases; or your organization's proprietary drug safety database.
Once an Oracle safety database is set up, you define data configurations in the Empirica Signal application to specify the source data available for data mining, and how it can be used. For example, if the source data includes both trade names and generic names for drugs, the data configuration can specify that data mining be performed using generic names only.
Once you have created data configurations, you can perform data mining runs. A data mining run extracts data from the source and applies a statistical algorithm to generate signal scores. The Empirica Signal application offers different algorithms as options for data mining runs:
Data mining runs in the Empirica Signal application generate scores that identify potential signals. Your organization determines whether those scores represent true signals.
Once a run is completed and published for use by other Empirica Signal users, reviewers can view the resulting signal scores in tabular or graphical format. They can select criteria to choose results for review and sort the results as needed. Reviewers can also choose a variety of options for displaying the table or graph. If a hierarchy is available, representing different levels for drug or event terms, reviewers can specify terms at any of these hierarchical levels before reviewing results. For example, a reviewer can view the scores for combinations of a particular drug and any event in a particular MedDRA System Organ Class (SOC), the highest level in the MedDRA event hierarchy.
If appropriate site options and permissions are set up, Empirica Signal users can drill down from run results to view the list of cases involved. For example, the combination of DrugA and EventB has a high signal score and there are 12 cases with that drug-event combination. The reviewer can drill down to view a list of those 12 cases, and then drill down to detailed information about any of those cases.
Reviewers can also print tables or graphs of results and download them for use in applications such as Microsoft Excel (.xls, .csv) or Microsoft Word (.rtf).
Signal management is an optional feature in the Empirica Signal application to view disproportionality analysis statistics for successive updates of safety data, allowing monitoring and evaluating of changes in safety signals over time.
You can query the source data based on criteria that you specify. You can save the query results as a case series, which is a list of cases of interest.
In addition to reports that are delivered with the Empirica Signal application, you can construct your own reports by specifying which variables to include as columns and which variables determine report rows. There are two types of reports:
Note: A special type of interactive report is the All Cases Summary report, which is used for drug profiles.
On the Drugs tab, you can view drug profiles, which are presentations of statistical and other information about one or more selected drugs. Depending on how the drug profile feature is set up, you can view existing charts or create your own. Drug profiles are made up of charts, which can be either of the following:
A drug profile layout is a saved collection of charts, as well as their placement and display options.
On the Topics tab, you can organize and track tables, graphs, and documents related to particular subject matter. For example, issues identified through various means, such as automated signal detection, literature review, regulatory requests, and so on, can be saved as attachments to a topic.
You can set up topics to follow workflow through different states, such as Initial, Reviewed, and Closed. You can also assign topics to users and make them visible to work teams.