PEDIATRICS Vol. 97 No. 1 January 1996, pp. 113-114
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Practice-based Outcomes Research: Crucial, Feasible, and Neglected

Jerry Avorn MD1

1 Department of Medicine, Program for the Analysis of Clinical Strategies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA

The article from the Vermont-Oxford Neonatal Network1 in this issue of Pediatrics comparing two surfactant preparations represents an important case study of a central issue in contemporary medicine: the need for rigorous, even-handed evaluation of competing therapies. Even at a time in which patients and payers are expecting ever-higher standards for clinical outcomes, and policymakers and insurers are demanding more and more stringent cost containment, the American health care system lacks a coherent mechanism for assembling and analyzing the data needed to meet these goals. For pharmacologic therapies, the Food and Drug Administration (FDA) prefers that mew agents be tested against placebos whenever possible, unless this would result in harm to experimental subjects.