Об этом курсе
4.7
1,103 ratings
203 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....
Globe

Только онлайн-курсы

Начните сейчас и учитесь по собственному графику.
Calendar

Гибкие сроки

Назначьте сроки сдачи в соответствии со своим графиком.
Clock

Предполагаемая нагрузка: 4 hours/week

Прибл. 10 ч. на завершение
Comment Dots

English

Субтитры: English

Приобретаемые навыки

Clinical ResearchTrial DesignClinical Trial DesignClinical Trial Management
Globe

Только онлайн-курсы

Начните сейчас и учитесь по собственному графику.
Calendar

Гибкие сроки

Назначьте сроки сдачи в соответствии со своим графиком.
Clock

Предполагаемая нагрузка: 4 hours/week

Прибл. 10 ч. на завершение
Comment Dots

English

Субтитры: English

Программа курса: что вы изучите

1

Раздел
Clock
2 ч. на завершение

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 видео (всего 56 мин.), 3 материалов для самостоятельного изучения, 1 тест
Video5 видео
Lecture 1A: Comparison Structure: Parallel, Crossover, and Group Allocation Designs18мин
Lecture 1B: Extensions of the Parallel Design: Factorial and Large Simple Designs10мин
Lecture 1C: Testing for Hypotheses Other than Superiority: Equivalency and Non-Inferiority Designs12мин
Lecture 1D: Adaptive Design11мин
Reading3 материала для самостоятельного изучения
Welcome Message10мин
Syllabus10мин
Pre-Course Survey10мин
Quiz1 практическое упражнение
Quiz 120мин

2

Раздел
Clock
2 ч. на завершение

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 видео (всего 67 мин.), 1 материал для самостоятельного изучения, 1 тест
Video3 видео
Lecture 2B: Types of Schemes32мин
Lecture 3: Masking18мин
Reading1 материал для самостоятельного изучения
Welcome to Week 210мин
Quiz1 практическое упражнение
Quiz 220мин

3

Раздел
Clock
2 ч. на завершение

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 видео (всего 51 мин.), 1 материал для самостоятельного изучения, 1 тест
Video4 видео
Lecture 4B: Influence on Design12мин
Lecture 5A: Analysis by Assigned Treatment (Intention to Treat)10мин
Lecture 5B: Subgroup Analysis6мин
Reading1 материал для самостоятельного изучения
Welcome to Week 310мин
Quiz1 практическое упражнение
Quiz 320мин

4

Раздел
Clock
2 ч. на завершение

Ethics

This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans. ...
Reading
2 видео (всего 17 мин.), 6 материалов для самостоятельного изучения, 1 тест
Video2 видео
Lecture 6B: Contemporary Ethical Issues5мин
Reading6 материала для самостоятельного изучения
Welcome to Week 410мин
The Belmont Report10мин
Common Rule 45CFR4610мин
Declaration of Helsinki10мин
HIPAA Privacy Rule Booklet10мин
The Nuremberg Code10мин
Quiz1 практическое упражнение
Quiz 420мин
4.7
Direction Signs

36%

начал новую карьеру, пройдя эти курсы
Briefcase

83%

получил значимые преимущества в карьере благодаря этому курсу

Лучшие рецензии

автор: 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

автор: 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.

Преподавателя

Janet Holbrook, PhD, MPH

Associate Professor, Epidemiology
Bloomberg School of Public Health

Lea T. Drye, PhD

Assistant Scientist, Epidemiology
Bloomberg School of Public Health

О 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....

Часто задаваемые вопросы

  • 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.

Остались вопросы? Посетите Центр поддержки учащихся.