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.
Offered By
Design and Interpretation of Clinical Trials
About this Course
Learner Career Outcomes
39%
36%
14%
Skills you will gain
Learner Career Outcomes
39%
36%
14%
Shareable Certificate
100% online
Flexible deadlines
Approx. 11 hours to complete
English
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
4.7
TOP REVIEWS FROM DESIGN AND INTERPRETATION OF CLINICAL TRIALS
High quality course ! covering important areas and detailed lectures, more and better than a mere introduction. Congrats ! My only regret : I'd have liked to hear more about NI and equivalence 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.
This course is well-designed, well-paced and well-structured. The study examples described in this course really help you understand the importance of design and interpretation of clinical trials.
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.
One of the best online courses I have taken so far at Coursera. Very helpful if you are new to the field and helps you to understand and interpret clinical data. I highly recommend this course.
This course really helped me to understand trials and gave me starting knowledge about how to design a trial. But it is not enough itself, and you should consider taking biostatistics classes.
I was able to learn a lot from this course. The lectures and the sequence of the presentations were logical and clear to understand. I will definitely recommend this course for my colleagues.
The powerpoints and audio lectures are very clear and concise, much appreciated. I would also appreciate more exercises or reading materials, to help solidify our understanding of the topics.
Great course for not only a better understanding of the clinically directed people but also for sales professionals to help understand and discuss clinical findings for their products.
Succinct course which includes a good overview of clinical trial design as well as additional readings for deeper understanding of FDA requirements and guidelines for clinical trials.
I work as a protocol activation coordinator for a large clinical trials office. I am new to this role and this course was very valuable in helping me get started with this career
Frequently Asked Questions
When will I have access to the lectures and assignments?
Once you enroll for a Certificate, you’ll have access to all videos, quizzes, and programming assignments (if applicable). Peer review assignments can only be submitted and reviewed once your session has begun. If you choose to explore the course without purchasing, you may not be able to access certain assignments.
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.
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Is financial aid available?
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