SYSTEM AND METHOD FOR PHARMACOVIGILANCE

摘要

A method and system for analyzing a relationship between agents and clinical outcomes is disclosed. The method includes: receiving a selection of one or more agents; receiving a selection of one or more clinical outcomes; for each of the one or more agents, analyzing clinical data stored in a database to determine a number of occurrences of each of the one or more clinical outcomes when the agent is administered; for each of the one or more agents, calculating a risk score for each clinical outcome corresponding to the number of occurrences of the clinical outcome; and outputting the risk scores to a graphical display. The displayed information can also be scaled and filtered for ease of use. Also, the results may be stratified into sub-populations.

主权项

1. A method for displaying a graphical representation of relationships between a plurality of agents and a plurality of clinical outcomes, the method comprising:
receiving, by a processor included in a computing device, a selection of a plurality of agents; receiving, by the processor, a selection of a plurality of clinical outcomes; analyzing, by the processor, clinical data stored in a database to determine a number of occurrences for each clinical outcome when one or more agents are administered to a plurality of patients having a first clinical condition; calculating, by the processor, for each agent-clinical outcome pairing, a count for a number of patients having the first clinical condition, that were administered the agent of the agent-clinical outcome pairing, and had the clinical outcome of the agent-clinical outcome pairing; calculating, by the processor, for each agent-clinical outcome pairing, a relative risk score for patients having the first clinical condition, that were administered the agent of the agent-clinical outcome pairing, and had the clinical outcome of the agent-clinical outcome pairing; calculating, by the processor, for each agent-clinical outcome pairing, a statistical significance value for the relative risk score corresponding to the agent-clinical outcome pairing; displaying, on a display device, a first graphical user interface that includes a first two-dimensional grid in which one or more agents are displayed in a first axis and one or more clinical outcomes are displayed in a second axis, wherein a given agent-clinical outcome pairing is displayed in the first graphical user interface if the count for the agent-clinical outcome pairing exceeds a first threshold, the relative risk score for the agent-clinical outcome pairing exceeds a second threshold, and the statistical significance value for the relative risk score for the agent-clinical outcome pairing exceeds a third threshold; displaying, on the display device, at least one graphical user interface element capable of being engaged by a user, wherein the at least one graphical user interface element corresponds to one or more of the first threshold value, the second threshold value, and the third threshold value; receiving, by the processor, an adjustment from the user to the at least one graphical user interface element, wherein the adjustment causes one or more of the first threshold value, the second threshold value, and the third threshold value to be increased; and in response to the adjustment, displaying, on the display device, a second graphical user interface that includes a second two-dimensional grid in which one or more agents are displayed in a first axis and one or more clinical outcomes are displayed in a second axis, wherein fewer agent-clinical outcome pairings are displayed in the second graphical user interface than are displayed in the first graphical user interface.