 |
 |
 |
 |
 |
 |
 |
Member Information
Susan Ellenberg, Ph.D.
Professor of Biostatistics
Associate Dean for Clinical Research
University of Pennsylvania School of Medicine
Office Phone: 215-573-8533
Office Fax: 215-573-4865
Email: sellenbe@mail.med.upenn.edu
Websites:
Education: PhD, George Washington University
Keywords:
Research and/or Clinical Interests:
Summary:
Susan S. Ellenberg, Ph.D., joined the Division of Biostatistics, Center for Clinical Epidemiology and Biostatistics, in December 2004. She also serves as Associate Dean for Clinical Research in the School of Medicine . Dr. Ellenberg received her undergraduate training at Radcliffe College and earned a Ph.D. in mathematical statistics at the George Washington University . Prior to her arrival at Penn, Dr. Ellenberg was Director of the Office of Biostatistics and Epidemiology at the Center for Biologics Evaluation and Research, FDA (1993-2004), Chief of the Biostatistics Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases (1988-92), and Mathematical Statistician, Biometrics Research Branch, Cancer Therapy Evaluation Program, National Cancer Institute (1982-88). Before her federal government service, she had positions at the EMMES Corporation (1979-82) and the George Washington University (1972-79).
Dr. Ellenberg's research interests have focused on issues in the design and analysis of clinical trials, and assessment of medical product safety. Particular areas of interest include efficient trial designs, interim monitoring and the operation of data monitoring committees, evaluation of surrogate endpoints, ethical issues in clinical research, and special issues in trials of cancer and AIDS therapies, and of vaccines. She serves as Associate Editor of Clinical Trials and of the Journal of the National Cancer Institute. Dr. Ellenberg is a Fellow of the American Statistical Association and the American Association for the Advancement of Science, and an elected member of the International Statistical Institute. She has served as President of the Society for Clinical Trials and the Eastern North American Region of the International Biometric Society, and has chaired the Statistics Section of the AAAS. Her recent book on clinical trials data monitoring committees, co-authored with Drs. Thomas Fleming ( University of Washington ) and David DeMets (University of Wisconsin), was named WileyEurope Statistics Book of the Year for 2002.
Recent Publications:
*Ellenberg, S.S. Independent data monitoring committees: rationale, operations and controversies. Statistics in Medicine, 20: 2573-2583, 2001.
*Temple , R., Ellenberg, S.S. Placebo-controlled trials and active control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Annals of Internal Medicine, 133:455-463, 2000.
*Ellenberg, S.S., Temple , R. Placebo-controlled trials and active control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Annals of Internal Medicine, 133:464-470, 2000.
*Fleming, T.R., Ellenberg, S.S., DeMets, D.L. Monitoring clinical trials: issues and controversies regarding confidentiality. Statistics in Medicine, 21:2843-2851, 2002.
*Califf, R.M., Ellenberg, S.S. Statistical approaches and policies for the operation of data and safety monitoring committees. American Heart Journal, 141: 289-294, 2001.
*Ellenberg, S.S. Safety considerations for new vaccine development. Pharmacoepidemiology and Drug Safety, 10:411-15, 2001.
*Ellenberg, S.S. Surrogate endpoints: the debate goes on (invited editorial). Pharmacoepidemiology and Drug Safety, 10:493-496, 2001.
*Ellenberg S.S., Braun M.M. Monitoring the safety of vaccines: assessing the risks. Drug Safety, 25:145-152, 2002.
*Silvers L.E., Varricchio F.E., Ellenberg S.S., et al. Pediatric deaths reported after vaccination; the utility of information obtained from parents. American Journal of Preventive Medicine, 22:430-435, 2002.
*Brody BA, Dickey N, Ellenberg SS, et al. Is the use of placebo controls ethically permissible in clinical trials of agents intended to reduce fractures in osteoporosis? Journal of Bone and Mineral Research, 18:1105-1109, 2003.
*Ellenberg S.S. Scientific and ethical issues in the use of placebo and active controls in clinical trials. Journal of Bone and Mineral Research, 18:1121-1124, 2003.
*Ellenberg S.S. Analytical, practical and regulatory issues in prevention studies. Statistics in Medicine, 23:297-303, 2004.
*Ellenberg, S.S. Are all monitoring boundaries equally ethical? (Invited commentary). Controlled Clinical Trials, 24:585-588, 2003.
*Ellenberg, S.S. and George, S.L. Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership? Statistics in Medicine, 23:1503-1505, 2004.
*Ellenberg, S.S. Monitoring data on data monitoring. (Invited editorial) Clinical Trials, 1:6-8, 2004.
*Mohan, A.K., Braun, M.M., Ellenberg, S.S., Hedje, J., Cote, T.R. Deaths among children less than 2 years of age receiving palivizumab: an analysis of co-morbidities. Pediatric Infectious Disease Journal, 23:342-345, 2004.
*DeMets, D., Califf R., Dixon D, Ellenberg, S., Fleming, T. et al. Issues in regulatory guidelines for data monitoring committees. Clinical Trials, 1:162-169, 2004.
*Folb, P.I., Bernatowska, E., Chen, R., Clemens, J., Dodoo, A.N., Ellenberg, S., et al. A global perspective on vaccine safety and public health: the Global Advisory Committee on Vaccine Safety. American Journal of Public Health, 94: 1926-1931, 2004.
*Ellenberg, S.S., Foulkes, M.A., Midthun, K. , Goldenthal, K.L. Evaluation of new vaccines: how much safety data? Summary of a workshop. American Journal of Public Health, in press.
Books
*Ellenberg, S.S., Fleming T.R., DeMets D.L. Data Monitoring Committees in Clinical Trials: A Practical Perspective. John Wiley & Sons, London , 2002.
