Published Mar 17, 2013

Manchester, UK - In the article, “Innovative Data Analysis for Demonstrating Product Value: Analysis of Heterogeneity in Treatment Response in Clinical Trials,” published in Vol. 19 Issue 1 of ISPOR CONNECTIONS, Dr. Donald E. Stull and Katherine Houghton assessed an example of new methods for identifying subgroups of differential responders to treatment. The innovative analyses -- growth mixture models -- were conducted using data from the Studies of Left Ventricular Dysfunction (SOLVD), a clinical trial that assessed the effects of an angiotensin converting enzyme (ACE) -inhibitor, an antihypertensive, on hospitalizations and mortality. In a single analysis, subgroups of differential responders to treatment were identified. Patients who were identified as more responsive to treatment within the treatment arm had fewer heart-failure–related hospitalizations and were less likely to die than patients in the placebo arm. "These innovative methods have the potential to efficiently identify patients who are more responsive to treatment, moving us closer to personalized medicine," notes Dr. Stull, lead author of the study. "In addition, they can help inform later trial design by suggesting changes to inclusion and exclusion criteria based on characteristics of more responsive patients."

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