Here are some published case studies of MedDRA use by the biopharmaceutical industry.
MedDRA and Analysis of Risk and Specific Events
An industry-sponsored study examined aspects of the safety profile of recombinant activated Factor VII (rFVIIa), specifically the rate of thromboembolic complications, by evaluating the rate of such events in published randomized, placebo-controlled trials involving off label use of rFVIIa. It was noted that there was a perceived increased risk of thromboembolic events when rFVIIa is used in an off-label basis. The adverse event data from the studies were coded in MedDRA, and for the purpose of analysis, the terms were grouped into related arterial thromboembolic events (coronary, cerebrovascular and other) and venous thromboembolic events. There was an increased risk of arterial thromboembolic events among those who received off-label rFVIIa vs. those who received placebo. Increasing age and dose also increased the risk.
Levi M, Levy JH, Andersen HF, Truloff D. Safety of recombinant activated Factor VII in randomized clinical trials. N Engl J Med 2010 Nov;363(19):1791-800.
MedDRA and Signal Detection Approaches
In this study, a large global pharmaceutical company examined Individual Case Safety Reports (ICSRs) for 14 new and established medicines and compared two safety signal detection approaches, namely, the Multi-item Gamma Poisson Shrinker (MGPS) and Logistic Regression (LR) for known and unknown safety topics. Adverse event information in the ICSRs was coded using MedDRA. Standardised MedDRA Queries (SMQs) and MedDRA term queries created by the company were also part of the methodology of this study. The results showed comparable performance between the two signal detection methods, and the best performance was with leading terms in “narrow” MedDRA queries.
Berlin C, Blanch C, Lewis DJ, Maladorno DD, Michel C, Petrin M et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and multi-item gamma Poisson Shrinker. Pharmacoepidemiol Drug Saf 2012 Jun;21(6):622-30. doi: 10.1002/pds.2247. Epub 2011 Oct 12.