MPTX 522: Clinical Design

It is unknown how many promising compounds have been rejected because they were evaluated in a study with a poor design. Well-designed clinical trials are essential in the development process of a medication or device. Before developing and executing a clinical trial, essential features which must be considered include: 1) basic study design; 2) study population; 3) planned statistical analysis; 4) enrollment of subjects; 5) regulatory requirements; and 6) ethical issues. In this course the student will explore and become familiar with clinical research designs and statistical analyses utilized in medical-product research. The course will also highlight the unique features of clinical trials in specialized populations such as AIDS, cancer, pediatrics and psychiatry. Current trends for accelerating drug development will also be covered.