Clinical Trials Analysis, Monitoring, and Presentation
In this course, you’ll learn more advanced operational skills that you and your team need to run a successful clinical trial. You’ll learn about the computation of sample size and how to develop a sample size calculation that’s suitable for your trial design and outcome measures. You’ll also learn to use statistical methods to monitor your trial for safety, integrity, and efficacy. Next, you’ll learn how to report the results from your clinical trials through both journal articles and data monitoring reports.
Monthly Subscription Starting at AED 99 + VAT
- Level Foundation
- Duration 5 hours
- Course by Johns Hopkins University
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Offered by
About
In this course, you’ll learn more advanced operational skills that you and your team need to run a successful clinical trial. You’ll learn about the computation of sample size and how to develop a sample size calculation that’s suitable for your trial design and outcome measures. You’ll also learn to use statistical methods to monitor your trial for safety, integrity, and efficacy. Next, you’ll learn how to report the results from your clinical trials through both journal articles and data monitoring reports. Finally, we’ll discuss the role of the analyst throughout the trial process, plus a few additional topics such as simulations and adaptive designs.Modules
Welcome to the Course!
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1
Readings
1
Readings
- Welcome to the course!
Clinical Trial Sample Size
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3
Videos
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1
Assignment
1
Assignment
- Bias Control Randomization and Masking
3
Videos
- Definitions and Introduction
- Sampling and Assumptions
- Practicalities
Trial Monitoring
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4
Videos
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1
Assignment
1
Assignment
- Trial Monitoring
4
Videos
- Goals and Responsibilities
- Interim Analyses
- Safety Versus Efficacy Data
- Statistical Monitoring
Reporting Results From Randomized Clinical Trials (RCTs)
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4
Videos
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1
Assignment
1
Assignment
- Reporting Results from Randomized Clinical Trials
4
Videos
- Journal Articles
- Nuts and Bolts of Journal Articles
- Tables and Figures
- Data Monitoring Reports for RCTs
Analyzing Trials
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5
Videos
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1
Assignment
1
Assignment
- Analyzing Trials
5
Videos
- Role of the Analyst
- Statistical Analysis Plan
- Analysis Population
- Analysis Considerations
- Types of Analyses
Advanced Topics
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3
Videos
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1
Readings
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1
Assignment
1
Assignment
- Advanced Topics
3
Videos
- Simulations
- Adaptive Designs
- Bayesian Approaches
1
Readings
- Closing Thoughts
Auto Summary
"Clinical Trials Analysis, Monitoring, and Presentation" is a foundational health and fitness course offered by Coursera. Ideal for those seeking advanced operational skills to run successful clinical trials, it covers sample size computation, statistical monitoring for safety and efficacy, and result reporting through journal articles and data monitoring reports. The course also discusses the analyst's role in trials, simulations, and adaptive designs. With a 300-hour duration, it offers flexible learning through Starter and Professional subscription options, making it perfect for healthcare professionals aiming to enhance their clinical trial expertise.
Janet Holbrook, PhD, MPH
Elizabeth A. Sugar, PhD
David M. Shade, JD