À propos de ce cours
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.
Globe

Cours en ligne à 100 %

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

Approx. 10 hours to complete

Recommandé : 3 hours/week
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.
Clock

Approx. 10 hours to complete

Recommandé : 3 hours/week
Comment Dots

English

Sous-titres : English

Syllabus - What you will learn from this course

1

Section
Clock
2 hours to complete

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 videos (Total 56 min), 3 readings, 1 quiz
Video5 videos
Lecture 1A: Comparison Structure: Parallel, Crossover, and Group Allocation Designs18m
Lecture 1B: Extensions of the Parallel Design: Factorial and Large Simple Designs10m
Lecture 1C: Testing for Hypotheses Other than Superiority: Equivalency and Non-Inferiority Designs12m
Lecture 1D: Adaptive Design11m
Reading3 readings
Welcome Message10m
Syllabus10m
Pre-Course Survey10m
Quiz1 practice exercises
Quiz 120m

2

Section
Clock
2 hours to complete

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 videos (Total 67 min), 1 reading, 1 quiz
Video3 videos
Lecture 2B: Types of Schemes32m
Lecture 3: Masking18m
Reading1 readings
Welcome to Week 210m
Quiz1 practice exercises
Quiz 220m

3

Section
Clock
2 hours to complete

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 videos (Total 51 min), 1 reading, 1 quiz
Video4 videos
Lecture 4B: Influence on Design12m
Lecture 5A: Analysis by Assigned Treatment (Intention to Treat)10m
Lecture 5B: Subgroup Analysis6m
Reading1 readings
Welcome to Week 310m
Quiz1 practice exercises
Quiz 320m

4

Section
Clock
2 hours to complete

Ethics

This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans. ...
Reading
2 videos (Total 17 min), 6 readings, 1 quiz
Video2 videos
Lecture 6B: Contemporary Ethical Issues5m
Reading6 readings
Welcome to Week 410m
The Belmont Report10m
Common Rule 45CFR4610m
Declaration of Helsinki10m
HIPAA Privacy Rule Booklet10m
The Nuremberg Code10m
Quiz1 practice exercises
Quiz 420m

5

Section
Clock
2 hours to complete

Reporting Results

This week, we focus on reporting results of clinical trials in publications. We cover the Consolidated Standards of Reporting Trials (CONSORT) guidelines....
Reading
3 videos (Total 31 min), 3 readings, 1 quiz
Video3 videos
Lecture 7B: CONSORT Guidelines21m
Lecture 7C: Evaluating Literature3m
Reading3 readings
Welcome to Week 510m
Reporting of noninferiority and equivalence randomized trials10m
The CONSORT Statement10m
Quiz1 practice exercises
Quiz 520m

6

Section
Clock
1 hour to complete

Randomized Clinical Trials

This week, we focus on whether RCTs are still the gold standard for evaluating evidence. ...
Reading
3 videos (Total 39 min), 2 readings, 1 quiz
Video3 videos
Lecture 8B: High-Profile Cases30m
Wrap-Up Video 1m
Reading2 readings
Welcome to Week 610m
Post Course Survey10m
Quiz1 practice exercises
Quiz 620m
4.7
Direction Signs

36%

started a new career after completing these courses
Briefcase

83%

got a tangible career benefit from this course

Top Reviews

By 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.

By 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.

Instructors

Avatar

Janet Holbrook, PhD, MPH

Associate Professor, Epidemiology
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Lea T. Drye, PhD

Assistant Scientist, Epidemiology

About 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....

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