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Design and Interpretation of Clinical Trials

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Design and Interpretation of Clinical Trials

Universidade Johns Hopkins

Informações sobre o curso: 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.


Desenvolvido por:  Universidade Johns Hopkins
Universidade Johns Hopkins

  • Janet Holbrook, PhD, MPH

    Ministrado por:  Janet Holbrook, PhD, MPH, Associate Professor, Epidemiology

    Bloomberg School of Public Health

  • Lea T. Drye, PhD

    Ministrado por:  Lea T. Drye, PhD, Assistant Scientist, Epidemiology

    Bloomberg School of Public Health
Idioma
English
Como ser aprovadoSeja aprovado em todas as tarefas para concluir o curso.
Classificação do usuário
4.7 estrelas
Classificação média do usuário 4.7Veja o que os aprendizes disseram
Programa
SEMANA 1
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.
5 vídeos, 3 leituras
  1. Vídeo: Welcome Video
  2. Leyendo: Welcome Message
  3. Leyendo: Syllabus
  4. Leyendo: Pre-Course Survey
  5. Vídeo: Lecture 1A: Comparison Structure: Parallel, Crossover, and Group Allocation Designs
  6. Vídeo: Lecture 1B: Extensions of the Parallel Design: Factorial and Large Simple Designs
  7. Vídeo: Lecture 1C: Testing for Hypotheses Other than Superiority: Equivalency and Non-Inferiority Designs
  8. Vídeo: Lecture 1D: Adaptive Design
  9. Cuadro de aviso de la discusión: Examples of clinical trials that you know about
  10. Cuadro de aviso de la discusión: Why did they choose that design?
Nota atribuída: Quiz 1
SEMANA 2
Randomization and Masking
This week we discuss two key design features of randomized clinical trials used to protect against bias, randomization and masking.
3 vídeos, 1 leitura
  1. Leyendo: Welcome to Week 2
  2. Vídeo: Lecture 2A: Rationale for Randomization
  3. Vídeo: Lecture 2B: Types of Schemes
  4. Vídeo: Lecture 3: Masking
  5. Cuadro de aviso de la discusión: Why is flipping a coin a bad randomization scheme?
  6. Cuadro de aviso de la discusión: Analyze a treatment assignment list
  7. Cuadro de aviso de la discusión: Simple, Restrictive, or Adaptive
Nota atribuída: Quiz 2
SEMANA 3
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.
4 vídeos, 1 leitura
  1. Leyendo: Welcome to Week 3
  2. Vídeo: Lecture 4A: Outcomes: Definitions & Types
  3. Vídeo: Lecture 4B: Influence on Design
  4. Vídeo: Lecture 5A: Analysis by Assigned Treatment (Intention to Treat)
  5. Vídeo: Lecture 5B: Subgroup Analysis
  6. Cuadro de aviso de la discusión: Tell us about outcomes in clinical trials you know about
  7. Cuadro de aviso de la discusión: Chat about how adherence is measured in clinical trials
Nota atribuída: Quiz 3
SEMANA 4
Ethics
This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans.
2 vídeos, 6 leituras
  1. Leyendo: Welcome to Week 4
  2. Vídeo: Lecture 6A: Equipoise, IRBs, and HIPAA
  3. Vídeo: Lecture 6B: Contemporary Ethical Issues
  4. Leyendo: The Belmont Report
  5. Leyendo: Common Rule 45CFR46
  6. Leyendo: Declaration of Helsinki
  7. Leyendo: HIPAA Privacy Rule Booklet
  8. Leyendo: The Nuremberg Code
  9. Cuadro de aviso de la discusión: What are the advantages of using a placebo versus an active control?
  10. Cuadro de aviso de la discusión: Access to experimental treatments - in the news
Nota atribuída: Quiz 4
SEMANA 5
Reporting Results
This week, we focus on reporting results of clinical trials in publications. We cover the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
3 vídeos, 3 leituras
  1. Leyendo: Welcome to Week 5
  2. Vídeo: Lecture 7A: Reporting Results from Trials
  3. Vídeo: Lecture 7B: CONSORT Guidelines
  4. Vídeo: Lecture 7C: Evaluating Literature
  5. Leyendo: Reporting of noninferiority and equivalence randomized trials
  6. Leyendo: The CONSORT Statement
  7. Cuadro de aviso de la discusión: Your experience with incomplete trial reporting
  8. Cuadro de aviso de la discusión: Bias in writing and publishing trials
Nota atribuída: Quiz 5
SEMANA 6
Randomized Clinical Trials
This week, we focus on whether RCTs are still the gold standard for evaluating evidence.
3 vídeos, 2 leituras
  1. Leyendo: Welcome to Week 6
  2. Vídeo: Lecture 8A: Are Randomized Clinical Trials Still the Gold Standard?
  3. Vídeo: Lecture 8B: High-Profile Cases
  4. Cuadro de aviso de la discusión: Inconsistent findings
  5. Cuadro de aviso de la discusión: Observational studies
  6. Vídeo: Wrap-Up Video
  7. Leyendo: Post Course Survey
Nota atribuída: Quiz 6

Perguntas frequentes
Como funciona
Trabajo del curso
Trabajo del curso

Cada curso es como un libro de texto interactivo, con videos pregrabados, cuestionarios y proyectos.

Ayuda de tus compañeros
Ayuda de tus compañeros

Conéctate con miles de estudiantes y debate ideas y materiales del curso, y obtén ayuda para dominar los conceptos.

Certificados
Certificados

Obtén reconocimiento oficial por tu trabajo y comparte tu éxito con amigos, compañeros y empleadores.

Desenvolvedores
Universidade Johns Hopkins
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.
Classificações e avaliações
Avaliado em 4.7 de 5 decorrente de 953 avaliações

SC

Very informative course for the beginners

SD

the quiz questions can be more in-depth

Hoang Bao Long

The knowledge you'll learn and obtain in this course is rich and very helpful. Please spend time watching the videos and reviewing the materials carefully.

JL

Good. easy, and informative



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