Design and Interpretation of Clinical Trials
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Course Summary
This course provides an introduction to clinical trials, including the various types of trials, the steps involved in designing and conducting a trial, and the ethical and regulatory considerations involved. Students will learn about the importance of clinical trials and their role in advancing medical research.Key Learning Points
- Learn about the different types of clinical trials and their design
- Understand the ethical and regulatory considerations involved in clinical trials
- Discover the importance of clinical trials in advancing medical research
Job Positions & Salaries of people who have taken this course might have
- Clinical Research Coordinator
- USA: $46,000 - $94,000
- India: INR 2,00,000 - INR 10,00,000
- Spain: €20,000 - €40,000
- Clinical Research Associate
- USA: $54,000 - $121,000
- India: INR 3,00,000 - INR 15,00,000
- Spain: €28,000 - €50,000
- Medical Writer
- USA: $57,000 - $112,000
- India: INR 3,00,000 - INR 12,00,000
- Spain: €22,000 - €46,000
Related Topics for further study
- Clinical trial design
- Ethical considerations
- Regulatory considerations
- Medical research
- Clinical research careers
Learning Outcomes
- Understand the importance of clinical trials in medical research
- Learn about the different types of clinical trials and their design
- Understand the ethical and regulatory considerations involved in clinical trials
Prerequisites or good to have knowledge before taking this course
- Basic knowledge of medical terminology
- Undergraduate degree in a related field
Course Difficulty Level
IntermediateCourse Format
- Online self-paced
- Video lectures
- Quizzes and assignments
Similar Courses
- Introduction to Epidemiology
- Clinical Data Science
Related Education Paths
Notable People in This Field
- Dr. Eric Topol
- Dr. Harlan Krumholz
Related Books
Description
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.
Outline
- Types of Trial Designs
- Welcome Video
- Lecture 1A: Comparison Structure: Parallel, Crossover, and Group Allocation Designs
- Lecture 1B: Extensions of the Parallel Design: Factorial and Large Simple Designs
- Lecture 1C: Testing for Hypotheses Other than Superiority: Equivalency and Non-Inferiority Designs
- Lecture 1D: Adaptive Design
- Welcome Message
- Syllabus
- Pre-Course Survey
- Quiz 1
- Randomization and Masking
- Lecture 2A: Rationale for Randomization
- Lecture 2B: Types of Schemes
- Lecture 3: Masking
- Welcome to Week 2
- Quiz 2
- Outcomes and Analysis
- Lecture 4A: Outcomes: Definitions & Types
- Lecture 4B: Influence on Design
- Lecture 5A: Analysis by Assigned Treatment (Intention to Treat)
- Lecture 5B: Subgroup Analysis
- Welcome to Week 3
- Quiz 3
- Ethics
- Lecture 6A: Equipoise, IRBs, and HIPAA
- Lecture 6B: Contemporary Ethical Issues
- Welcome to Week 4
- The Belmont Report
- Common Rule 45CFR46
- Declaration of Helsinki
- HIPAA Privacy Rule Booklet
- The Nuremberg Code
- Quiz 4
- Reporting Results
- Lecture 7A: Reporting Results from Trials
- Lecture 7B: CONSORT Guidelines
- Lecture 7C: Evaluating Literature
- Welcome to Week 5
- Reporting of noninferiority and equivalence randomized trials
- The CONSORT Statement
- Quiz 5
- Randomized Clinical Trials
- Lecture 8A: Are Randomized Clinical Trials Still the Gold Standard?
- Lecture 8B: High-Profile Cases
- Wrap-Up Video
- Welcome to Week 6
- Post Course Survey
- Quiz 6
Summary of User Reviews
Learn about clinical trials in this comprehensive course on Coursera. Users have found the course to be informative and engaging, with practical applications for their work in the healthcare industry.Key Aspect Users Liked About This Course
Users found the practical applications of the course to be particularly helpful in their work in the healthcare industry.Pros from User Reviews
- Informative and engaging content
- Practical applications for healthcare industry
- Well-structured course materials
- Excellent instructor
- Good mix of theory and practice
Cons from User Reviews
- Some users found the course to be too basic
- Limited interaction with other students
- Some technical issues with the online platform
- Not enough focus on statistical analysis
- Some users felt the course was too focused on pharmaceutical clinical trials
Janet Holbrook, PhD, MPH
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Design and Interpretation of Clinical Trials
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Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e....
