This IMA Volume in Mathematics and its Applications STATISTICAL MODELS IN EPIDEMIOLOGY, THE ENVIRONMENT,AND CLINICAL TRIALS is a combined proceedings on "Design and Analysis of Clinical Trials" and "Statistics and Epidemiology: Environment and Health. " This volume is the third series based on the proceedings of a very successful 1997 IMA Summer Program on "Statistics in the Health Sciences. " I would like to thank the organizers: M. Elizabeth Halloran of Emory University (Biostatistics) and Donald A. Berry of Duke University (Insti­ tute of Statistics and Decision Sciences and Cancer Center Biostatistics) for their excellent work as organizers of the meeting and for editing the proceedings. I am grateful to Seymour Geisser of University of Minnesota (Statistics), Patricia Grambsch, University of Minnesota (Biostatistics); Joel Greenhouse, Carnegie Mellon University (Statistics); Nicholas Lange, Harvard Medical School (Brain Imaging Center, McLean Hospital); Barry Margolin, University of North Carolina-Chapel Hill (Biostatistics); Sandy Weisberg, University of Minnesota (Statistics); Scott Zeger, Johns Hop­ kins University (Biostatistics); and Marvin Zelen, Harvard School of Public Health (Biostatistics) for organizing the six weeks summer program. I also take this opportunity to thank the National Science Foundation (NSF) and the Army Research Office (ARO), whose financial support made the workshop possible. Willard Miller, Jr.