À propos de ce cours
4.7
1,061 ratings
199 reviews
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....
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Clock

Recommandé : 4 hours/week

Approx. 10 heures pour terminer
Comment Dots

English

Sous-titres : English

Compétences que vous acquerrez

Clinical Trial DesignClinical ResearchTrial DesignClinical Trial Management
Globe

Cours en ligne à 100 %

Commencez dès maintenant et apprenez aux horaires qui vous conviennent.
Calendar

Dates limites flexibles

Réinitialisez les dates limites selon votre disponibilité.
Clock

Recommandé : 4 hours/week

Approx. 10 heures pour terminer
Comment Dots

English

Sous-titres : English

Programme du cours : ce que vous apprendrez dans ce cours

1

Section
Clock
2 heures pour terminer

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....
Reading
5 vidéos (Total 56 min), 3 lectures, 1 quiz
Video5 vidéos
Lecture 1A: Comparison Structure: Parallel, Crossover, and Group Allocation Designs18 min
Lecture 1B: Extensions of the Parallel Design: Factorial and Large Simple Designs10 min
Lecture 1C: Testing for Hypotheses Other than Superiority: Equivalency and Non-Inferiority Designs12 min
Lecture 1D: Adaptive Design11 min
Reading3 lectures
Welcome Message10 min
Syllabus10 min
Pre-Course Survey10 min
Quiz1 exercice pour s'entraîner
Quiz 120 min

2

Section
Clock
2 heures pour terminer

Randomization and Masking

This week we discuss two key design features of randomized clinical trials used to protect against bias, randomization and masking....
Reading
3 vidéos (Total 67 min), 1 lecture, 1 quiz
Video3 vidéos
Lecture 2B: Types of Schemes32 min
Lecture 3: Masking18 min
Reading1 lecture
Welcome to Week 210 min
Quiz1 exercice pour s'entraîner
Quiz 220 min

3

Section
Clock
2 heures pour terminer

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....
Reading
4 vidéos (Total 51 min), 1 lecture, 1 quiz
Video4 vidéos
Lecture 4B: Influence on Design12 min
Lecture 5A: Analysis by Assigned Treatment (Intention to Treat)10 min
Lecture 5B: Subgroup Analysis6 min
Reading1 lecture
Welcome to Week 310 min
Quiz1 exercice pour s'entraîner
Quiz 320 min

4

Section
Clock
2 heures pour terminer

Ethics

This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans. ...
Reading
2 vidéos (Total 17 min), 6 lectures, 1 quiz
Video2 vidéos
Lecture 6B: Contemporary Ethical Issues5 min
Reading6 lectures
Welcome to Week 410 min
The Belmont Report10 min
Common Rule 45CFR4610 min
Declaration of Helsinki10 min
HIPAA Privacy Rule Booklet10 min
The Nuremberg Code10 min
Quiz1 exercice pour s'entraîner
Quiz 420 min
4.7
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Meilleurs avis

par AMMar 20th 2016

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.

par TJJun 2nd 2018

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.

Enseignants

Janet Holbrook, PhD, MPH

Associate Professor, Epidemiology
Bloomberg School of Public Health

Lea T. Drye, PhD

Assistant Scientist, Epidemiology
Bloomberg School of Public Health

À propos de 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....

Foire Aux Questions

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