Division of Biometrics I
Office of Biostatistics, Office of Translational Science
Center for Drug Evaluation and Research
Silver Spring, MD

Research Interests:

Throughout his 20+ years with CDER of FDA, Dr. Hung has been conducting extensive research on factorial design trials, utility of p-value distribution, adaptive design/analysis, non-inferiority trials, and multi-regional trials. His research was supported by a number of CDER RSR funds. In addition to research, Dr. Hung has been contributing to several FDA/CDER working groups such as non-inferiority guidance group, adaptive design guidance group.

Proposed Research Project for FDA Fellow:

Working with Dr. Hung, the fellow will participate in biostatistical research relevant to regulatory science, particularly in the areas of clinical trial design/analysis methodology and the statistical principle for interpretation of scientific evidence to help enhance drug development programs. In particular, the innovative designs such as non-inferiority design and adaptive design that deviate greatly from the conventional clinical trial designs have a great many of challenges and controversies in terms of the methods for statistical inference and logistic issues. Multi-regional clinical trials have become reality and been faced with the serious problems of interpretability of trial results because of large regional differences seen in many regulatory applications. There is a dire need of research to enhance trial design for minimizing regional differences. Future directions of research in these areas include assessment of utility and pitfalls of these trial designs, management of trial conduct and data quality issues.

Selected Recent Publications:

1. Hung, H.M.J., Wang, S.J., O';Neill, R (2007). "Statistical considerations fortesting multiple endpoints in group sequential or adaptive clinical trials", Journal of Biopharmaceutical Statistics 17, 1201-1210.
2. Hung, H.M.J., Wang, S.J., O'Beill, R. (2007). "Non-inferiority trials", Encyclopedia of Clinical Trials, John Wiley & Sons.
3. Hung, H.M.J., Wang, S.J., O'Neill, R (2007). "Issues with statistical risks for testing methods in noninferiority trial without a placebo arm", Journal of Biopharmaceutical Statistics 17, 201-213.
4. Hung, H.M.J. (2007). "Some considerations in use of adaptive design in global clinical trial program", Japan's Critical Path Opportunities - Advanced and
5. Global Drug Development Techniques, the 7th Kitasato University – Harvard School of Public Health Symposium, Ed. by M. Takeuchi and S. Lagakos, 193-202.
6. Hung, H.M.J. (2006). Discussion on "Adaptive clinical trial designs: ready for prime time?" 2004 Workshop jointly sponsored by FDA and Harvard-MIT
7. Division of Health Science and Technology, Statistics in Medicine 26, 3313-3314.
8. Hung, H.M.J., O'Neill, R., Wang, S.J., Lawrence, J. (2006). "A regulatory view on adaptation/flexible clinical trial design", Biometrical Journal 48, 565-573.
9. Hung, H.M.J., Wang, S.J., O'Neill, R. (2006). "Methodological issues with adaptation of clinical trial design", Pharmaceutical Statistics 5, 99-107.
10. Hung, H.M.J., Wang, S.J., O'Neill, R. (2005). "A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials", Biometrical Journal 47, 28-36.
11. Hung, H.M.J., Wang, S.J., Tsong, Y., Lawrence, J., O'Neill, R.T. (2003), "Some fundamental issues with non-inferiority testing in active controlled clinical trials", Statistical in Medicine 22, 213-225.

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