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Biostatistics and Epidemiology

Faculty Profile

  • Weichung (Joe) Shih, PhD

  • Professor Emeritus

  • Department of Biostatistics and Epidemiology

  • CV

Adaptive designs in clinical trials; sample size re-estimation; missing data; sequential trials; Multi-regional clinical trials (MRCT); cancer studies; precision medicine with biomarkers; data and safety monitoring board.

PhD in Statistics, University of Minnesota, 1981.

Research Interests
Dr. Shih has been teaching, doing research and participating in clinical research, especially in clinical trials, since 1983. He continues to read, write, and provide consultations in all aspects of design issues and analytical methods in improving efficiency for clinical research. For example, the common problem of missing data is one area that affects almost all clinical studies. The balance between clinical practice and scientific experiment is the key consideration and source of controversy in clinical trials. He devoted a textbook (2015), based on his research and experience, to teach students as they are the next generation to develop new methods for improving public health through evidence-based clinical research with statistical skills.   

Research Highlights

Presented the first paper (1989) at the Society for Clinical Trials that opened a new field of research and coined the term "sample size re-estimation" in clinical trials. This new field was then joined by others and rapidly developed into all kinds of "adaptive designs" that reshaped the future of clinical trials. Published the first paper (2001) in calling a new paradigm using consistency criteria for drug registration in Asian regional countries. This field of research was adopted by the International Harmonization Conference (ICH) for bridging studies, which then became the new guidance (ICH E-17) for Multiregional clinical trials (MRCT) for global drug development

Select Publications
Shih, W., Lin, Y. (2018) "Relative efficiency of precision medicine designs for clinical trials with predictive biomarkers.", Statistics in Medicine Vol. 37

Shih, W., Lin, Y. (2017) "On study designs and hypotheses for clinical trials with predictive biomarkers.", Contemporary Clinical Trials Vol. 62

Li, G., Shih, W. (2017) "", Average Inferiority Measure and Standardized Margins to Address Issues in Biosimilar Trials in Biosimilar Clinical Development: Scientific Considerations and New Methodologies Vol. 0

Wang , P., Lu , S., Shih , W., Lan , K. (2017) "Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin", Journal of Statistical Planning and Inference Vol. 183

Shih, W., Li, G., Wang, Y. (2016) "Methods for flexible sample-size design in clinical trials: Likelihood, weighted, dual test, and promising zone approaches.", Contemporary Clinical Trials Vol. 47

Shih , W. (2016) "", Bridging Studies versus Multiregional Trials in Multiregional Clinical Trials for Simultaneous Global New Drug Development Vol. 0

Shih, W. (2016) "Comments on the three papers by the FDA/CDER research team on the regulatory perspective of the missing data problem.", Statistics in Medicine Vol. 35

Shih , W., Asiner , J. (2015) "", Statistical Design and Analysis of Clinical Trials: Principles and Methods Vol. 0

Little, R., D'Agostino, R., Cohen, M., Dickersin, K., Emerson, S., Farrar, J., Frangakis, C., Hogan, J., Molenberghs, G., Murphy, S., Neaton, J., Rotnitzky, A., Scharfstein, D., Shih, W., Siegel, J., Stern, H. (2012) "The prevention and treatment of missing data in clinical trials.", The New England Journal of Medicine Vol. 367

Little, R., Cohen, M., Dickersin, K., Emerson, S., Farrar, J., Neaton, J., Shih, W., Siegel, J., Stern, H. (2012) "The design and conduct of clinical trials to limit missing data.", Statistics in Medicine Vol. 31

Shih, W., Quan, H. (2012) "", Consistency of Treatment Effects in Bridging Studies and Global Multiregional Trials in Design and Analysis of Bridging Studies (Chapter 3) Vol. 0

Lu-Yao, G., Albertsen, P., Moore, D., Shih, W., Lin, Y., DiPaola, R., Barry, M., Zietman, A., O'Leary, M., Walker-Corkery, E., Yao, S. (2009) "Outcomes of localized prostate cancer following conservative management.", JAMA Vol. 302

Lu-Yao, G., Albertsen, P., Moore, D., Shih, W., Lin, Y., DiPaola, R., Yao, S. (2008) "Survival following primary androgen deprivation therapy among men with localized prostate cancer.", JAMA Vol. 300

Scholarly Activities
Editorial board, Statistics in Medicine (2000)

Outstanding Contribution and Support Award - Sino-American Pharmaceutical Professional Association (2014) - Recognize and support educational excellence achieved.

Excellence in Research Award - The UMDNJ Foundation (2011) - Excellence in Research Awards to recognize outstanding research activities.

Elected Member - International Statistical Institute (ISI) (2009) - ISI Elected membership is open to individuals who are established in their careers and have made significant contributions to the statistical profession.

Fellow of the American Statistical Association - American Statistical Association (1996) - The designation of ASA Fellow has been a significant honor for nearly 100 years.