About this Course
4.7
1,135 ratings
207 reviews
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100% online

Start instantly and learn at your own schedule.
Flexible deadlines

Flexible deadlines

Reset deadlines in accordance to your schedule.
Hours to complete

Approx. 11 hours to complete

Suggested: 4 hours/week...
Available languages

English

Subtitles: English...

Skills you will gain

Clinical ResearchTrial DesignClinical Trial DesignClinical Trial Management
100% online

100% online

Start instantly and learn at your own schedule.
Flexible deadlines

Flexible deadlines

Reset deadlines in accordance to your schedule.
Hours to complete

Approx. 11 hours to complete

Suggested: 4 hours/week...
Available languages

English

Subtitles: English...

Syllabus - What you will learn from this course

Week
1
Hours to complete
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 exercise
Quiz 120m
Week
2
Hours to complete
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 reading
Welcome to Week 210m
Quiz1 practice exercise
Quiz 220m
Week
3
Hours to complete
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 reading
Welcome to Week 310m
Quiz1 practice exercise
Quiz 320m
Week
4
Hours to complete
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 exercise
Quiz 420m
4.7
207 ReviewsChevron Right
Career direction

36%

started a new career after completing these courses
Career Benefit

83%

got a tangible career benefit from this course

Top Reviews

By TSJul 4th 2018

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

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.

Instructors

Avatar

Janet Holbrook, PhD, MPH

Associate Professor, Epidemiology
Bloomberg School of Public Health
Avatar

Lea T. Drye, PhD

Assistant Scientist, Epidemiology
Bloomberg School of Public Health

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....

Frequently Asked Questions

  • Once you enroll for a Certificate, you’ll have access to all videos, quizzes, and programming assignments (if applicable). Peer review assignments can only be submitted and reviewed once your session has begun. If you choose to explore the course without purchasing, you may not be able to access certain assignments.

  • When you purchase a Certificate you get access to all course materials, including graded assignments. Upon completing the course, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.

More questions? Visit the Learner Help Center.