Susan Ellenberg, PhD
|Office Location||611, Blockley Hall|
|CCEB Appointment||Senior Scholar, Biostatistics|
|Primary Faculty Appointment||Professor of Biostatistics at HUP, University of Pennsylvania Perelman SOM|
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 is an Associate Editor of Clinical Trials and of the Journal of the National Cancer Institute. Dr. Ellenberg is a Fellow of the American Statistical Association, the American Association for the Advancement of Science, the Society for Clinical Trials, 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, has chaired the Statistics Section of the AAAS and will serve as Chair of the Board of Trustees for the National Institute of Statistical Sciences beginning in 2011. Her 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.
BST 786/EPID 730: Advanced Topics in Clinical Trials
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 95:800-807, 2005.
Berlin JA, Glasser SC, Ellenberg SS.Adverse event detection in drug development:recommendations and obligations beyond phase 3. Am J Pub Health 98(8):1366, 2008.
Berlin JA, Ellenberg SS.Inclusion of women in clinical trials. BMC Medicine 7:56, 2009.
Ellenberg, S.S., Fleming T.R., DeMets D.L. Data Monitoring Committees in Clinical Trials: A Practical Perspective. John Wiley & Sons, London, 2002.