Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is effective because trials incorporates features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased. The FDA requires that drugs or biologics (e.g., vaccines) are shown to be effective in clinical trials before they can be sold in the US.
Design and Interpretation of Clinical Trials
Johns Hopkins UniversityAbout this Course
Learner Career Outcomes
26%
27%
13%
Skills you will gain
Learner Career Outcomes
26%
27%
13%
Offered by
Johns Hopkins University
The mission of The Johns Hopkins University is to educate its students and cultivate their capacity for life-long learning, to foster independent and original research, and to bring the benefits of discovery to the world.
Syllabus - What you will learn from this course
Types of Trial Designs
This week, we explore different types of trial designs, including parallel, crossover, group allocation, factorial, large simple, equivalency, non-inferiority, and adaptive designs.
Randomization and Masking
This week we discuss two key design features of randomized clinical trials used to protect against bias, randomization and masking.
Outcomes and Analysis
This week focuses on a key design issue - selecting the primary outcome. We will also cover the gold standard for analysis of clinical trials, which is including all the participants in the analysis regardless of their actual treatment.
Ethics
This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans.
Reviews
TOP REVIEWS FROM DESIGN AND INTERPRETATION OF CLINICAL TRIALS
This course would be most useful to the participant if pursued within a short time-frame, of maximum of 6 weeks. Both lecturers were clear and good communicators. I would take more of their classes.
Excellent beginner course on design and interpretation of clinical trials, complements a lot of what I reviewed on my classes and I would like to take a more advanced course on the topic. Thank you.
I would highly recommend this course as I found it well-structured and helpful. After studying all the materials, I gained a great amount of knowledge in designing and interpretating clinical trail.
Very good balance of general and in-depth content as well as technical and non-technical information. Well structured so it is easy to follow. Both presenters have an adequate pace and clear voice.
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