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.
Offert par
Design et interprétation des essais cliniques
Université Johns-HopkinsÀ propos de ce cours
Compétences que vous acquerrez
- Clinical Research
- Trial Design
- Clinical Trial Design
- Clinical Trial Management
Offert par
Université Johns-Hopkins
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.
Programme de cours : ce que vous apprendrez dans ce cours
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.
Avis
- 5 stars75,94 %
- 4 stars21,16 %
- 3 stars2,44 %
- 2 stars0,25 %
- 1 star0,18 %
Meilleurs avis pour DESIGN ET INTERPRÉTATION DES ESSAIS CLINIQUES
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.
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.
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.
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
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