Informações sobre o curso
4.7
1,056 ratings
198 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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Sugerido: 4 hours/week

Aprox. 10 horas restantes
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English

Legendas: English

Habilidades que você terá

Clinical Trial DesignClinical ResearchTrial DesignClinical Trial Management
Globe

cursos 100% online

Comece imediatamente e aprenda em seu próprio cronograma.
Calendar

Prazos flexíveis

Redefinir os prazos de acordo com sua programação.
Clock

Sugerido: 4 hours/week

Aprox. 10 horas restantes
Comment Dots

English

Legendas: English

Programa - O que você aprenderá com este curso

1

Seção
Clock
2 horas para concluir

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 vídeos (Total de 56 min), 3 leituras, 1 teste
Video5 videos
Lecture 1A: Comparison Structure: Parallel, Crossover, and Group Allocation Designs18min
Lecture 1B: Extensions of the Parallel Design: Factorial and Large Simple Designs10min
Lecture 1C: Testing for Hypotheses Other than Superiority: Equivalency and Non-Inferiority Designs12min
Lecture 1D: Adaptive Design11min
Reading3 leituras
Welcome Message10min
Syllabus10min
Pre-Course Survey10min
Quiz1 exercício prático
Quiz 120min

2

Seção
Clock
2 horas para concluir

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 vídeos (Total de 67 min), 1 leitura, 1 teste
Video3 videos
Lecture 2B: Types of Schemes32min
Lecture 3: Masking18min
Reading1 leituras
Welcome to Week 210min
Quiz1 exercício prático
Quiz 220min

3

Seção
Clock
2 horas para concluir

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 vídeos (Total de 51 min), 1 leitura, 1 teste
Video4 videos
Lecture 4B: Influence on Design12min
Lecture 5A: Analysis by Assigned Treatment (Intention to Treat)10min
Lecture 5B: Subgroup Analysis6min
Reading1 leituras
Welcome to Week 310min
Quiz1 exercício prático
Quiz 320min

4

Seção
Clock
2 horas para concluir

Ethics

This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans. ...
Reading
2 vídeos (Total de 17 min), 6 leituras, 1 teste
Video2 videos
Lecture 6B: Contemporary Ethical Issues5min
Reading6 leituras
Welcome to Week 410min
The Belmont Report10min
Common Rule 45CFR4610min
Declaration of Helsinki10min
HIPAA Privacy Rule Booklet10min
The Nuremberg Code10min
Quiz1 exercício prático
Quiz 420min
4.7
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Melhores avaliações

por 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.

por 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.

Instrutores

Janet Holbrook, PhD, MPH

Associate Professor, Epidemiology
Bloomberg School of Public Health

Lea T. Drye, PhD

Assistant Scientist, Epidemiology
Bloomberg School of Public Health

Sobre 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....

Perguntas Frequentes – FAQ

  • 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.

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