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Small Clinical Trials: Issues and Challenges (2001)

Chapter: Appendix D Committee and Staff Biographies

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Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
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Appendix D

Committee and Staff Biographies

COMMITTEE BIOGRAPHIES

Robert M. Centor, M.D., is professor of medicine, director of the Division of General Internal Medicine, and associate dean for Primary Care and Continuing Medical Education at the University of Alabama School of Medicine. Dr. Centor maintains an active interest in medical decision making, cost-effectiveness analysis, and outcomes research.

Ed Davis, Ph.D., is the chairman of the Department of Biostatistics in the School of Public Health at the University of North Carolina Chapel Hill. He received a Ph.D. in experimental statistics from North Carolina State University. He is an applied statistician with research interests in the design, conduct, and analysis of data from clinical trials and prospective epidemiological studies. His statistical research is in nonparametric methods.

Suzanne T. Ildstad, M.D., is a specialist in small-number-participant clinical trials, director of the Institute for Cellular Therapeutics, and The Jewish Hospital Distinguished Professor of Transplantation and Surgery at the University of Louisville. Dr. Ildstad received a medical degree from the Mayo Medical School in Rochester, Minnesota, followed by a residency in general surgery at the Massachusetts General Hospital, an immunology fellowship

Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
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at the National Institutes of Health, and a pediatric surgery-transplant surgery fellowship in Cincinnati. Her research in mixed chimerism to induce tolerance to organ allografts and treat nonmalignant diseases such as sickle cell anemia and autoimmune disorders is being applied clinically in six Food and Drug Administration-approved phase I trials. Dr. Ildstad holds several patents related to her research in expanding bone marrow transplantation to treat nonmalignant disease by optimizing the risk-benefit ratio through graft engineering and partial conditioning. She is the founding scientist of Chimeric Therapies, Inc., a biotechnology company focused on bone marrow graft engineering, and she serves on the board of directors of the company. Dr. Ildstad is a member of the Institute of Medicine, is serving as correspondent for the Committee on Human Rights, and is a member of the Institute of Medicine Committees on Organ Procurement and Transplantation and Multiple Sclerosis: Current Status and Strategies for the Future.

Bruce Levin, Ph.D., is professor and head of the Division of Biostatistics at the Columbia School of Public Health. He received a Ph.D. from Harvard University and has been on the faculty at Columbia University since 1974. His research interests are in biostatistics, data analysis, logistic regression, and sequential analysis. He is principal investigator of the Statistics, Epidemiology, and Data Management Core of the HIV Center for Clinical and Behavioral Studies. He is the senior statistical consultant on several multicenter randomized clinical trials in the field of stroke neurology and cardiology, including the Warfarin and Aspirin Recurrent Stroke Study and its collaborative trials. Dr. Levin has also served for the past 8 years as a consulting statistical editor for the American Journal of Public Health. He has a long-standing interest in the intersection of statistical inference for categorical data and computational methods in statistics. This interest has resulted in the development of analytical methods for a variety of problems from a unified viewpoint (that of finite and infinite dimensional linear exponential families). A product of this work is the unique computing program MCLA for maximum conditional likelihood analysis of polytomous outcome data in large-scale epidemiological data sets with arbitrary levels of stratification. Dr. Levin also studies general empirical Bayes methods (e.g., to test homogeneity hypotheses in large sparse data sets). Using these methods, Dr. Levin explores alternative designs for clinical trials, including nonrandomized designs that ensure allocation of new treatment to those subjects in most dire need of therapy. A related area of interest is sequential trial design, both classical and innovative (e.g., designs that minimize ethical costs).

Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
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Edward D. Miller, M.D., was named chief executive officer of Johns Hopkins Medicine, the 13th dean of The Johns Hopkins University School of Medicine, and vice president for medicine of The Johns Hopkins University in January 1997. He received an A.B. from Ohio Wesleyan University and an M.D. from the University of Rochester School of Medicine and Dentistry. He was a surgical intern at University Hospital in Boston, chief resident in anesthesiology at Peter Bent Brigham Hospital in Boston, and a research fellow in physiology at the Harvard Medical School. In 1981–1982, he spent a sabbatical year as senior scientist at Hôpital Necker in Paris. He joined Hopkins in 1994 as professor and chairman of the Department of Anesthesiology and Critical Care Medicine, a post he held until May 1999. He was named interim dean of the School of Medicine in 1996. He came to Hopkins after 8 years at Columbia University in New York, where he served as professor and chairman of the Department of Anesthesiology in the College of Physicians and Surgeons. Before that he spent 11 years at the University of Virginia in Charlottesville, where he rose from assistant professor to professor of anesthesiology and surgery and medical director of the Surgical Intensive Care Unit. Dr. Miller's research has focused on the cardiovascular effects of anesthetic drugs and vascular smooth muscle relaxation. He has served as president of the Association of University Anesthesiologists and editor of Anesthesia and Analgesia and of Critical Care Medicine. Elected to the Royal College of Anaesthetists in London in 1993, he has served on the board of the International Anesthesia Research Society and from 1991 to 1994 was chair of the Food and Drug Administration's Advisory Committee on Anesthesia and Life Support Drugs. A member of the Institute of Medicine of the National Academy of Sciences, Dr. Miller has authored or co authored more than 150 scientific papers, abstracts, and book chapters.

Ingram Olkin, Ph.D., is professor of statistics and education at Stanford University. He received a doctorate in mathematical statistics from the University of North Carolina and before moving to Stanford was on the faculties of Michigan State University and the University of Minnesota, where he served as chair of the Department of Statistics. He has co written a number of books, including Inequalities: Theory of Majorization and its Applications (1979), Selecting and Ordering Populations (1980), Probability Models and Applications (1980), and most recently, Statistical Methods in Meta-Analysis (1985). Dr. Olkin has been an editor of the Annals of Statistics and an associate editor of Psychometrika, the Journal of Educational Statistics, and the Journal of the American Statistical Association. He has also served as chair of

Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
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the Committee of Applied and Theoretical Statistics, National Research Council, National Academy of Sciences, and president of the Institute of Mathematical Statistics. He has been an Overseas Fellow, Churchill College, Cambridge University; a Lady Davis Fellow, Hebrew University; an Alexander von Humboldt Fellow, University of Augsburg; and a Guggenheim Fellow. He received an honorary D.Sci from DeMontfort University; a Lifetime Contribution Award from the American Psychological Association, Division 5; and a Wilks Medal from the American Statistical Association. His recent interest has been methodology for research synthesis, and he has published both theoretical and applied papers in medicine. He is currently a fellow in the Primary Care Outcomes Research program. His work in meta-analysis was the subject of his R.A. Fisher Lecture at the Joint Statistical Meeting 2000.

David J. Tollerud, M.D., M.P.H., is professor of public health at the MCP Hahnemann University School of Public Health. He received an M.D. from Mayo Medical School and an M.P.H. from the Harvard School of Public Health. He served as a medical staff fellow in the Environmental Epidemiology Branch, National Cancer Institute; pulmonary fellow at Brigham and Women's and Beth Israel Hospitals in Boston; assistant professor of medicine at the University of Cincinnati; and associate professor of environmental and occupational health at the University of Pittsburgh Graduate School of Public Health. He is a fellow of the American College of Occupational and Environmental Medicine and the American College of Chest Physicians; a member of numerous professional societies, including the American Thoracic Society, the American Association of Immunologists, the Clinical Immunology Society, the American Public Health Association, and the American Association for the Advancement of Science; and a member of the editorial review board of the American Industrial Hygiene Association Journal.

Peter Tugwell, M.D., M.Sc., is professor and chair of the Department of Medicine at the University of Ottawa. He received an M.D. from the University of London. From 1979 to 1991 he was chair of the Department of Epidemiology and Biostatistics at McMaster University, and from 1987 to 1991 he was director of the McMaster Rheumatology Program/The Centre for Arthritic Diseases. He joined the University of Ottawa as chair of the Department of Medicine and as physician-in-chief at the Ottawa General Hospital in July 1991. Since coming to Ottawa he has been an investigator in the Loeb/University of Ottawa Clinical Epidemiology Unit. Dr. Tugwell was

Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
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awarded the 1997 Researcher of the Year Award from the Ottawa General Hospital. He has been actively involved in several international organizations. He was the founding director of the McMaster Training Centre for the International Clinical Epidemiology Network (INCLEN) from 1980 to 1991 and recently has served as Chair of the INCLEN Research Subcommittee. He was president of the Canadian Society for International Health from 1989 to 1991. Dr. Tugwell is currently director of the World Health Organization Collaborating Centre for Health Technology Assessment based in Ottawa. He is the author or coauthor of more than 260 published articles. His research interests are in rheumatology, cytokines, and health technology assessment.

HEALTH SCIENCES POLICY BOARD LIAISON

Robert Gibbons, Ph.D., is professor of biostatistics and director of the Center for Health Statistics at the University of Illinois at Chicago. He received his doctorate in statistics and psychometrics from the University of Chicago in 1981. In 1985 he received a young scientist award from the Office of Naval Research, which funded his statistical research in the areas of the analysis of multivariate binary data and the analysis of longitudinal data. Dr. Gibbons has also received additional grant support from the National Institutes of Health and the John D. and Catherine T. MacArthur Foundation. He currently has a research scientist award from the National Institutes of Health that provides full-time support for statistical research. Applications of Dr. Gibbons' work are widespread in the general areas of mental health and environmental sciences. Dr. Gibbons has authored more than 100 peer-reviewed scientific papers and two books. He is currently working on a book entitled Statistical Methods for Detection and Quantification of Environmental Contamination, which will be published by John Wiley & Sons. He served on the Institute of Medicine's Committee on Halcion: An Assessment of Data Adequacy and Confidence as well as the Institute of Medicine's Committee on Organ Procurement and Transplantation Policy. Dr. Gibbons also is a member of the Health Sciences Policy Board of the Institute of Medicine.

IOM STUDY STAFF BIOGRAPHIES

Charles H. Evans, Jr., M.D., Ph.D., is Senior Adviser for Biomedical and Clinical Research at the Institute of Medicine of the National Academies. A pediatrician and immunologist, he graduated with a B.S. in biology from

Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
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Page 206

Union College and an M.D. and a Ph.D. from the University of Virginia and trained in pediatrics at the University of Virginia Medical Center. From 1975 to 1998 he served as chief of the Tumor Biology Section at the National Cancer Institute and holds the rank of Captain (Ret.) in the U.S. Public Health Service with 27 years of service as a medical scientist at the National Institutes of Health in Bethesda, Maryland. Dr. Evans' research interests include carcinogenesis (the etiology of cancer), the normal immune system defenses to the development of cancer, and aerospace medicine. He discovered the ability of cytokines to directly prevent carcinogenesis and was the first to isolate a direct-acting anticarcinogenic cytokine for which he was awarded four U.S. patents. Dr. Evans is the author of more than 125 scientific articles and is the recipient of numerous scientific awards including the Outstanding Service Medal from the U.S. Public Health Service and the Wellcome Medal and Prize. He is a fellow of the American Association for the Advancement of Science, a fellow of the American Institute of Chemists, and a credentialed Fellow in Health Systems Administration of the American Academy of Medical Administrators. An active adviser to community medicine and higher education, he has served on the Board of Trustees of Suburban Hospital Health System and on the College of Arts & Sciences Board of Trustees at the University of Virginia. Dr. Evans is the study director for the Committee on Strategies for Small-Number-Participant Clinical Research Trials.

Veronica A. Schreiber, M.A., M.P.H., received an M.P.H. with concentration in epidemiology from the George Washington University in 1999. For her master's research project, she designed and conducted research on patient referral and consultation practices by physicians of the Ambulatory Care Department of the George Washington University Medical Center. Before her health research work, she held teaching positions in political science and international relations for 11 years at the University of the Philippines (1974 to 1980), University of Pittsburgh (1980 to 1983), Frostburg State University (1983 to 1984), and the University of Maryland European Division (1988 to 1989). She was a Ph.D. candidate at the University of Pittsburgh when she accepted a teaching position at Frostburg State University in 1983. She was a research consultant at the Bonn office of the European Institute for Environmental Policy (1987 to 1988) and a training specialist at the German Foundation for International Development (1988 to 1991). She is a member of the Pi Sigma Alpha (political science) National Honor Society and the Phi Theta Kappa International Honor Society. After several years of community volunteer work and as a full-time mother, Ms.

Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
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Page 207

Schreiber joined the Institute of Medicine as the research assistant for the Committee on Strategies for Small-Number-Participant Clinical Research Trials and the Committee on Creating a Vision for Space Medicine Beyond Earth Orbit.

Kathi E. Hanna, Ph.D., is a science and health policy consultant specializing in biomedical research policy, specifically, genetics, cancer, and reproductive technologies. Most recently, Dr. Hanna served as senior adviser to the National Bioethics Advisory Commission in its response to the president's request for recommendations regarding human cloning. Before that she was senior adviser to the President's Advisory Committee on Gulf War Veterans Illnesses, in which she assessed the effects of military service on the reproductive health of veterans. Dr. Hanna was a senior analyst at the congressional Office of Technology Assessment for 7 years and contributed to numerous science policy studies requested by committees of the U.S. Congress on biotechnology, human genetics, women's health, reproductive technologies, and bioethics. In 1989, Dr. Hanna spent a year at the Institute of Medicine, where she edited a book about the interface between biomedical research and politics. In the past decade, Dr. Hanna has also served as a consultant to the Howard Hughes Medical Institute, the National Institutes of Health, the Institute of Medicine, the Federation of American Societies of Experimental Biology, and several academic health centers. Before her work in Washington, D.C., Dr. Hanna was the genetics coordinator at Children's Memorial Hospital in Chicago. Dr. Hanna received an A.B. in biology from Lafayette College, an M.S. in human genetics from Sarah Lawrence College, and a doctorate from the School of Business and Public Management, George Washington University.

Tanya Lee is project assistant for the Small Clinical Trials Study and the Space Medicine Study in the Board of Health Science Policy of the Institute of Medicine. She has been with the National Academies since April 2000. Ms. Lee attended the University of Maryland Eastern Shore and Prince Georges Community College, pursuing a degree in the field of sociology.

Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
×
Page 201
Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
×
Page 202
Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
×
Page 203
Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
×
Page 204
Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
×
Page 205
Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
×
Page 206
Suggested Citation:"Appendix D Committee and Staff Biographies." Institute of Medicine. 2001. Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press. doi: 10.17226/10078.
×
Page 207
Small Clinical Trials: Issues and Challenges Get This Book
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Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false.

Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

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