A national strategy to develop pragmatic clinical trials infrastructure

Area of Science:

• Health Services Research
• Clinical Trials Methodology

Background:

• Comparative effectiveness research (CER) faces challenges due to the lack of infrastructure for pragmatic clinical trials (PCTs).
• PCTs differ from efficacy trials by being conducted in usual practice settings with diverse patient populations and less controlled protocols.

Purpose of the Study:

• To establish a learning network and deploy research infrastructure for pragmatic clinical trials.
• To identify high-priority PCTs and foster a shared resource for investigators and communities.

Main Methods:

• A 1-year learning network was initiated in 2012.
• A three-stage process involved network development, trial prioritization, and learning exercises.
• A network meeting culminated the year-long project.

Main Results:

• Five key recommendations were generated for network development, community engagement, regulatory issues, information technology, and research methods.
• The recommendations are designed for implementation within 24 months.
• The project aimed to create a sustained national infrastructure for PCTs.

Conclusions:

• The developed recommendations provide a roadmap for establishing a national infrastructure to support pragmatic clinical trials.
• Implementing these recommendations will enhance the capacity for conducting real-world comparative effectiveness research.