What is a pragmatic trial, and what methodological challenges should you consider?

This lecture presents the results of a 1-year learning network to recommend research infrastructure improvements that could be used to launch and sustain pragmatic clinical trials in the U.S. Recommendations are designed to lead toward a sustained national infrastructure for pragmatic trials and they address five target areas: developing a pragmatic trial data network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods.

Learning Objectives

After completing this course, you will be able to:

• Describe key factors that distinguish pragmatic trials from explanatory trials
• Define three dimensions that can be used to assess the impact of stakeholder engagement on pragmatic trials
• Explain informatics challenges associated with the design and conduct of pragmatic trials
• List common methodological challenges associated with the conduct and analysis of pragmatic trials
• Identify methods to improve the dissemination and implementation of pragmatic trial findings.