Hello everyone. Welcome to Design and Interpretation of Clinical Trials. My name is Lee Dry and I'm here with Janet Holbrook. And we're faculty in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. And we're very excited to be presenting our first course for Coursera. In this course, we're going to focus on randomized control trials, evaluating drugs, devices and procedures for the treatment and prevention of disease in humans. We're not going to focus on early phase trials. Those are frequently neither randomized or controls. Instead we'll emphasize trials that are designed to assess the relative benefits and risks of interventions, compared to placebos or other control treatments. >> We developed this class based on a course we teach at the Johns Hopkins Bloomberg School of Public Health. We teach the class online and on campus each year. We try to distill the essential elements from that course into this offering. Occasionally we may refer to another lecture, or reading that is not included in the Coursera version of the course. Please forgive those few occurrences where the lecture has a reference that does not directly link to the material in the Coursera class. Although there are no prerequisites for this class, it will be helpful for understanding all of the class material, if you have some basic knowledge about epidemiology and biostatistics. The class is six weeks long. And we have one or two lectures each week. In the first week, we'll cover trial designs. In the second week, we'll have two lectures. One on randomization and one on masking. And in week three, we'll cover both outcomes and analysis. In week four, we have a short lecture on ethics. But, we have several required readings. In week five, we'll talk about reporting the results from clinical trials. And we'll wrap up the course in week six by discussing whether or not trials are still considered the gold standard for evaluating treatments. >> There will be a graded quiz each week. There will be up to 10 questions on each quiz. In order to keep up with the class, you should listen to the lectures and take the quizzes each week as we go along. However, we recognize that there may be some weeks in which you're unable to do that. So we are allowing you until the end of the six weeks to take all of the quizzes. You will have three attempts per each weekly quiz. And you will receive the highest of those three attempts. There is a bank of quiz questions, so you won't get exactly the same quiz every time you take it. In order to pass the class, you need to take each weekly quiz. And you should have an overall average of 70 percent or higher. The quiz questions will come predominantly from the lectures, but we do have readings associated with the lectures to help you understand the material. We will open discussion threads on the discussion forum periodically. These may relate to clinical trials in the news or scientific articles related to that week's lectures. We encourage you to participate in the discussion forum in order to enrich your experience and help you explore some of the complexities involved in the design and interpretation of clinical trials. The discussion forum is a vibrant component of this course when we teach the full version of the class at Johns Hopkins. However, participation in the discussion forum is not required, and will not be included in the overall student evaluation. Successful completion of the class will be based solely on your quizzes. By the end of the class, you should have a basic understanding of the fundamental principles of the design and interpretation of randomized clinical trials. So let's get going.