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
39%
36%
14%
Skills you will gain
Learner Career Outcomes
39%
36%
14%
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.
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.
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.
The instructors have broken down the concepts in a very effective manner and have designed very thoughtful discussion prompts. The course really helped me understand the basics of clinical trials.
Frequently Asked Questions
When will I have access to the lectures and assignments?
Access to lectures and assignments depends on your type of enrollment. If you take a course in audit mode, you will be able to see most course materials for free. To access graded assignments and to earn a Certificate, you will need to purchase the Certificate experience, during or after your audit. If you don't see the audit option:
- The course may not offer an audit option. You can try a Free Trial instead, or apply for Financial Aid.
- The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
What will I get if I purchase the Certificate?
When you purchase a Certificate you get access to all course materials, including graded assignments. Upon completing the course, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.
Is financial aid available?
Yes, Coursera provides financial aid to learners who cannot afford the fee. Apply for it by clicking on the Financial Aid link beneath the "Enroll" button on the left. You’ll be prompted to complete an application and will be notified if you are approved. Learn more.
Will I earn university credit for completing the Course?
This Course doesn't carry university credit, but some universities may choose to accept Course Certificates for credit. Check with your institution to learn more. Online Degrees and Mastertrack™ Certificates on Coursera provide the opportunity to earn university credit.
More questions? Visit the Learner Help Center.
