Response by Packer to Letter Regarding Article, “Development and Evolution of a Hierarchical Clinical Composite End Point for the Evaluation of Drugs and Devices for Acute and Chronic Heart Failure: A 20-Year Perspective”
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The hierarchical clinical composite end point (HCCE) was developed to address 2 important goals in the analysis of clinical trial data: (1) to minimize the bias inherent in the censoring of important adverse events when the primary end point was focused entirely on a patient benefit, and (2) to expand the range of responses when the primary end point was focused entirely on the risk of an adverse event. Over the past 20 years, the hierarchical clinical composite has succeeded with respect to both goals, and yet, as I described in my article, …