ABSTRACT
Well-designed clinical trials have become the “gold standard” for the assessment of new treatments and comparison of alternate therapies in medicine. They have evolved as a joint discipline involving both medical and statistical science, and their rigorous methodology greatly strengthens the scientific foundation of clinical practice. This chapter is designed to review the background and rationale for clinical trials and to discuss principles of sound trial design, including analysis, interpretation, and presentation of results. Also, ethical issues are explored, costs and limitations are considered, and finally, some future trends in clinical trials and their applications are suggested.
