Authors:
Peter Mroz, Manager, Statistical Programmer, Methods, Analysis and Programming, Global Medical Safety, Janssen Pharmaceutical Companies of Johnson and Johnson
Geoff Gipson, Associate Director, Analytical Programming, Methods, Analysis and Programming, Global Medical Safety, Janssen Pharmaceutical Companies of Johnson and Johnson
Abstract:
Janssen Pharmaceuticals is responsible for actively monitoring the safety of hundreds of medicinal products. Analyzing drug adverse event reporting over time is a critical activity for proactively monitoring product safety and meeting regulatory expectations. Drug specific considerations create the need for a great deal of analytical and reporting customization which is a challenge to effectively manage. Here we present an end-user tool, PV-Trend, which allows medical reviewers to take complete control of their trending analyses through distributed analytics and provides an easy-to-use interface and storage of relevant information in Oracle.
PV-Trend provides an elegant mechanism for creating and managing complex safety “topics” using a harmonized adverse event ontology [medical dictionary for regulatory activities (MedDRA)], case report meta-data, and medically relevant case attributes. Once defined, topic-associated cases are aggregated into reporting fractions or reporting rates and evaluated for changes through time. Specifically, interval analyses and regression analyses are performed to identify discrete and consistent reporting changes, respectively.
PV-Trend has been developed using JMP® JSL for the user interface, analyses and graphs and Oracle for data storage and backend logic. This presentation will provide a general overview and then focus on some interesting technical details of the system.