Establishing Case Quality Metrics- The Sciformix experience

In Clinical Trials by Simon Crompton-ReidLeave a Comment

Measurement of case quality in pharmacovigilance is a relatively new development. Before pharmaceutical companies began outsourcing their case processing operations, the only measure of effectiveness of their internal operations was compliance with regulatory reporting timelines. Now that these operations are performed by vendors, over the last two years vendor management organizations within pharmaceutical companies and Health Authorities have come up with a way to measure the "quality" of Adverse Event (AE) cases. This paper captures the Sciformix experience and learning in defining and using case quality metrics while working with large and small pharmaceutical companies. Download the full paper here.

The inherent challenge in defining objective case quality metrics arises from the subjective nature of the work and from attempting to balance sponsor expectations vis-à-vis operational efficiencies. Until about 2009 compliance to reporting timelines of expedited reports by the Marketing Authorization Holders (MAH) was the only valid metric of the effectiveness of an AE processing operation evaluated by global health authorities (such as USFDA, EMEA, UK MHRA). The International Conference on Harmonization (ICH) defined time limits for reporting adverse events which varied from 7 days for death/life threatening adverse events from clinical studies to 15 days for serious, unexpected events from marketed products. This changed in 2009 due to the public focus on drug safety led by recalls of prominent drugs like Avandia, Vioxx etc. The regulators began to look closely at the way the pharmaceutical companies were classifying cases as reportable under the existing guidelines (serious unexpected adverse events) as against adverse events listed on the drug label, which are normally not reported individually but are compiled into aggregate periodic reports. There were instances where pharmaceutical companies used questionable criteria to "downgrade" reportable adverse events to non-serious, periodic adverse events for which they were cited by the USFDA during inspections. As a consequence, the health authorities began looking closely at "case quality", i.e., the appropriate disposition of the case, in addition to monitoring that the established timelines for regulatory reporting are met. Read more here…

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