Design and Conduct of Clinical Trials

Design and Conduct of Clinical Trials

This course is part of Clinical Trials Operations Specialization

Instructors: Janet Holbrook, PhD, MPH

What you'll learn

Evaluate and select clinical trial designs
Implement bias control measures
Randomize participants into groups
Define clinical trial outcomes

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

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There are 5 modules in this course

In this course, you’ll learn how to design and carry out clinical trials. Each design choice has implications for the quality and validity of your results. This course provides you and your team with essential skills to evaluate options, make good design choices, and implement them within your trial. You’ll learn to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. Finally, a trial without participants is no trial at all, so you’ll learn the guiding principles and develop the essential skills to ethically and conscientiously recruit, obtain consent from, and retain trial participants.

Every trial design depends on the skilled application of core design elements. In this module, you’ll learn about various approaches to bias control as well as simple, restricted, and adaptive approaches to trial participant randomization. Finally, you’ll learn to protect the validity of your results with masking procedures that conceal treatments and outcomes as necessary from the study team, participants, and outcomes assessors.

What's included

7 videos1 reading1 assignment

7 videosTotal 34 minutes

Bias3 minutesPreview module
Randomization17 minutes
Practical Tips for Randomization4 minutes
Primer: Intention-to-Treat Analysis Versus Per-Protocol Analysis2 minutes
Other Ways to Address Confounding in Clinical Trials1 minute
Masking4 minutes
Summary1 minute

1 readingTotal 3 minutes

Welcome to the Course3 minutes

1 assignmentTotal 9 minutes

Bias Control - Randomization and Masking9 minutes

Each trial is conducted in stages, so it’s critical that you and your team are prepared to make sound design choices for each stage. That includes developing and evaluating research questions and hypotheses, selecting among various design types, and identifying errors.

What's included

8 videos1 assignment

Well-defined outcomes are the foundation of any good trial design. The outcomes that you and your team establish at the beginning of the design process will influence other design decisions such as trial type, randomization, masking, sample size, and more.

What's included

4 videos1 assignment

Trials participants must be treated with the utmost respect, and that begins with careful attention to informed consent. In this module, you’ll learn about the personnel, documents, terminology, and practices that go into planning and implementing ethically sound informed consent procedures within your trial.

What's included

3 videos1 assignment

A trial without participants is no trial at all. In this module, you’ll learn how to ethically and effectively recruit and retain the participants you need for your trial and strategically select the clinical sites where you’ll conduct your research.