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.
Clinical Trials Analysis, Monitoring, and Presentation
Clinical Trials Analysis, Monitoring, and Presentation
This course is part of Clinical Trials Operations Specialization
Instructors: Janet Holbrook, PhD, MPH
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Gain insight into a topic and learn the fundamentals.
4.7
(66 reviews)
Beginner level
Recommended experience
4 hours to complete
3 weeks at 1 hour a week
Flexible schedule
Learn at your own pace
What you'll learn
Calculate clinical trial sample size
Monitor clinical trial performance
Analyze results from clinical trials
Communicate results from clinical trials
Details to know
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Assessments
5 assignments
Taught in English
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This course is part of the Clinical Trials Operations Specialization
When you enroll in this course, you'll also be enrolled in this Specialization.
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There are 5 modules in this course
Sample size calculation in clinical trials refers to the process for determining how large a trial needs to be in order to have a reasonable expectation of detecting a difference between groups. The end result of the sample size calculation should be an estimate of the number of observations.
What's included
3 videos1 reading1 assignment
In this module, you’ll learn about trial monitoring, which involves statistical methods to assess a trial while it is underway. These methods are used to assess safety, integrity, efficacy, recruitment, data collection, and data quality.
What's included
4 videos1 assignment
Skilled communication of your clinical trial results is critical to ensuring that your efforts have the intended impact. In this module, you’ll learn the best practices for reporting results in both journal publications and in data monitoring reports.
What's included
4 videos1 assignment
Analysts play an important role throughout the trial, not just at the end. In this module, you’ll learn about the analyst’s role, including how the analyst contributes to the trial at every stage of the process.
What's included
5 videos1 assignment
In this module, you’ll learn about some advanced operational functions that should be in your trial team’s toolkit, including simulations, adaptive designs, and Bayesian statistics.
What's included
3 videos1 reading1 assignment
Instructors
Instructor ratings
4.6 (20 ratings)Offered by
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Johns Hopkins University
Johns Hopkins University
Johns Hopkins University
Johns Hopkins University
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4.7
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KP
5
Reviewed on Aug 5, 2024
Awesome overview of the nuts and bolts of Clinical Trials for anyone looking to get started
SS
4
Reviewed on Dec 31, 2024
A bit of prior knowledge is must to fully understand this course and also strong grip of stats. overall a good course offered by JHU
NB
4
Reviewed on Feb 15, 2024
It covers the process of clinical trial. I would prefer the beginners in clinical research should do this course.
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Frequently asked questions
Access to lectures and assignments depends on your type of enrollment. If you take a course in audit mode, you will be able to see most course materials for free. To access graded assignments and to earn a Certificate, you will need to purchase the Certificate experience, during or after your audit. If you don't see the audit option:
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