The NIH Pragmatic Trials Collaboratory this week published a new chapter of its Living Textbook of Pragmatic Clinical Trials. The chapter, Decentralized Pragmatic Clinical Trials, covers activities of a pragmatic trial that can occur remotely—at a location separate from an investigator’s location—such as participant engagement, recruitment, consent, study interventions and procedures, collection of patient-reported outcomes, and follow-up.
The chapter describes special considerations for decentralized trials, such as community health considerations and the vigilance needed to assure data quality, particularly as it relates to adherence with the study intervention, outcome ascertainment, and event monitoring.
The new chapter includes the following sections:
- What Is a Decentralized Trial?
- What Decentralized Elements Are Used in Pragmatic Trials?
- Community Health Considerations for Decentralized Approaches
- Quality Assurance
Most of NIH Collaboratory Trials have decentralized elements, as described in detail in Section 2.