About Design and interpretation of clinical trials course
Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in people. Interventions evaluated may be drugs, devices (such as a hearing aid), surgeries, behavioral interventions (such as a smoking cessation program), population health programs (such as cancer screening programs), or health care delivery systems (such as hospital specialty care units). We consider clinical trials to be experiments because investigators, rather than patients or their doctors, choose the treatments patients receive. Results from randomized clinical trials are generally considered the highest level of evidence for determining the effectiveness of a treatment because the trials include features that ensure that the benefits and risks of the treatment are assessed objectively and unbiased. The FDA requires that drugs or biologics (such as vaccines) be proven effective in clinical trials before they can be marketed in the United States. This course will explain the basic principles of designing randomized clinical trials and how they should be presented. In the first part of the course, students will be introduced to the terminology used in clinical trials and some common designs used in clinical trials, such as parallel and crossover. We will also explain some of the mechanics of clinical trials, such as randomization and blinding of treatment. In the second half of the course, we will explain how clinical trial results are analyzed and interpreted. Finally, we will cover the main ethical issues involved in conducting experiments on humans.
