Abstract
Two important diseases in need of new antibacterial drugs are acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP). These are common infections in the United States, with millions of patients treated annually. The identification of well-defined and reliable efficacy outcome measures for ABSSSI and CABP would greatly assist in clinical trials of new antibacterial drugs to treat the 2 diseases. With a clear clinical and regulatory need for outcome measures for ABSSSI and CABP, we approached the Biomarkers Consortium of the Foundation for the National Institutes of Health about assembling a project team. In this issue of Clinical Infectious Diseases, the project team of the Biomarkers Consortium of the Foundation for the National Institutes of Health (FNIH PT), as part of their ongoing work, provides a summary of data reviews, opinions, and recommendations for primary efficacy outcome measures for ABSSSI and CABP that will support development of new antibacterial drugs [1]. Additional work is planned to further improve and refine outcome measures. The FNIH PT brought together a wide range of experts in infectious diseases, statistical sciences, and clinical trials research from the academic research community, biopharmaceutical companies, and government. A unique perspective of the FNIH PT was the retrospective evaluation of outcome measures in data from various clinical trials of biopharmaceutical sponsors. The enormous research value in evaluating these data within a single collaborative project is reflected in the work of the FNIH PT and its presentation in this issue of Clinical Infectious Diseases. An especially important contribution of the data evaluation by the FNIH PT is the public access that it provides in the form of documents submitted in response to each of the Food and Drug Administration draft guidance documents for ABSSSI and CABP [2,3]. The review of the historical literature,
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