Clinical Trials Analysis, Monitoring, and Presentation

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Clinical Trials Analysis, Monitoring, and Presentation

This course is part of Clinical Trials Operations Specialization

Instructors: Janet Holbrook, PhD, MPH

12,240 already enrolled

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5 modules

Gain insight into a topic and learn the fundamentals.

Beginner level

Recommended experience

5 hours to complete

Flexible schedule

Learn at your own pace

5 modules

Gain insight into a topic and learn the fundamentals.

Beginner level

Recommended experience

5 hours to complete

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

Skills you'll gain

Details to know

Shareable certificate

Add to your LinkedIn profile

Assessments

5 assignments

Taught in English

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Build your subject-matter expertise

This course is part of the Clinical Trials Operations Specialization

When you enroll in this course, you'll also be enrolled in this Specialization.

Learn new concepts from industry experts
Gain a foundational understanding of a subject or tool
Develop job-relevant skills with hands-on projects
Earn a shareable career certificate

There are 5 modules in this course

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.

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

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Add this credential to your LinkedIn profile, resume, or CV. Share it on social media and in your performance review.

Instructors

Janet Holbrook, PhD, MPH

Johns Hopkins University

4 Courses194,115 learners

Elizabeth A. Sugar, PhD

Johns Hopkins University

2 Courses34,828 learners

Offered by

Johns Hopkins University

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Frequently asked questions

To access the course materials, assignments and to earn a Certificate, you will need to purchase the Certificate experience when you enroll in a course. You can try a Free Trial instead, or apply for Financial Aid. The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.

When you enroll in the course, you get access to all of the courses in the Specialization, and you earn a certificate when you complete the work. Your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile.

Yes. In select learning programs, you can apply for financial aid or a scholarship if you can’t afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, you’ll find a link to apply on the description page.