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.
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Design and Interpretation of Clinical Trials
ジョンズ・ホプキンズ大学(Johns Hopkins University)このコースについて
習得するスキル
- Clinical Research
- Trial Design
- Clinical Trial Design
- Clinical Trial Management
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ジョンズ・ホプキンズ大学(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.
シラバス - 本コースの学習内容
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.
レビュー
- 5 stars75.93%
- 4 stars21.17%
- 3 stars2.45%
- 2 stars0.25%
- 1 star0.18%
DESIGN AND INTERPRETATION OF CLINICAL TRIALS からの人気レビュー
As a new learner of clinical trials, I learned a lot about the design of randomized clinical trials and the various factors that could impact the outcomes. I thorough;y enjoyed the course.
This course does a good job of introducing fundamental concepts necessary in Clinical Trials. I would recommend this course to anyone looking to build a foundation of knowledge on the field.
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.
Good course overall. Some information was complex and the slides were not always complete. I personally found the first 2-3 quizzes quite difficult. However, the course is useful and interesting.
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