About this course: 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. The course will explain the basic principles for design of randomized clinical trials and how they should be reported. In the first part of the course, students will be introduced to terminology used in clinical trials and the several common designs used for clinical trials, such as parallel and cross-over designs. We will also explain some of the mechanics of clinical trials, like randomization and blinding of treatment. In the second half of the course, we will explain how clinical trials are analyzed and interpreted. Finally, we will review the essential ethical consideration involved in conducting experiments on people.
Taught by: Janet Holbrook, PhD, MPH, Associate Professor, Epidemiology
Bloomberg School of Public Health
Taught by: Lea T. Drye, PhD, Assistant Scientist, Epidemiology
Bloomberg School of Public Health
| Language | English |
| How To Pass | Pass all graded assignments to complete the course. |
| User Ratings |
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Excellent and concise introduction to the design, analysis and report of clinical trials
Even if some of the topics might be considered "heavy" and boring, the organisers and presenters of this course made sure that everything was easy to understand.
Overall: Very useful for future work and topics were presented in an interesting way.
I've taken a couple of courses in Coursera and this was the best one so far! The lectures are engaging, clear and comprehensive, and the discussion prompts very useful. I would certainly take an advance course and recommend this one to all those interested in learning more on how clinical trials are designed and reported.
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sg
The course was very useful for me and came to know more about randomized clinical trials ,and other consort for writing trial design .it was very useful and i can add this certificate in my resume it will give weight to my resume for standing in clinical trial industry.and finally thanku for lecturers.they did an awesome job very keen on every topic explanations. hopefully expecting courses in clinical trials ,regulatory affairs
Thank you
sangavai