Introduction to clinical trials and other types of clinical research, bias and random error in clinical studies, overview of Phase I-IV trials, multi-center trials; randomized, controlled clinical trials; concept of blinding/masking in clinical trials.
Design of Phase 1-3 clinical trials: parallel vs. cross-over designs, cross-sectional vs. longitudinal designs, review of factorial designs, objectives and endpoints of clinical trials, formulation of appropriate hypotheses (equivalence, non-inferiority, etc.); sample size calculation; design for bioequivalence/ bioavailability trials, sequential stopping in clinical trials.
Analysis of Phase 1-3 trials: Use of generalized linear models; analysis of categorical outcomes, Bayesian and non-parametric methods; analysis of survival data from clinical trials Epidemiological studies: case-control and cohort designs; odds ratio and relative risk; logistic and multiple regression models.
S.C. Chow and J.P. Liu, Design and Analysis of Clinical Trials - Concepts & Methodologies, 3rd Edition, John Wiley Series in Probability and Statistics, October 2013.
S.C. Chow and J.P. Liu, Design and Analysis of Bioavailability & Bioequivalence Studies, 3rd Edition Chapman and Hall/CRC Marcel Dekker, October 2008.
W.W. Daniel and C. L. Cross, Biostatistics: A Foundation for Analysis in the Health Sciences (10th ed.), John Wiley, NewYork, 2013. J.L. Fleiss
The Design and Analysis of Clinical Experiments, John Wiley Interscience, 1999. D.W. Hosmer and S. Lemeshow and R.X.Sturdivant
Applied Logistic Regression, 3rd Edition, John Wiley and Sons, NY, 2013. E. Vittinghoff, D.V. Glidden and S.C. Shiboski
Regression Methods in Biostatistics: Liner, Logostics, Survival and Repeated Measures Models(Statistics for Biology and Health) 2nd Edition Springer Verlag, March 2012. J.G. Ibrahim, M-H Chen and D. Sinha, Bayesian survival analysis, Springer, NY, 2001.