How PCORnet® Could Advance Postmarket Evidence Generation.

Area of Science:

• Health Services Research
• Clinical Trials Methodology
• Health Informatics

Background:

• The vision for a learning health system necessitates efficient evidence generation.
• The US Food and Drug Administration (FDA) supports initiatives to accelerate research.
• Postmarket clinical trials are crucial for evaluating real-world effectiveness and safety.

Purpose of the Study:

• To discuss the potential of PCORnet and similar national networks in facilitating streamlined clinical trials.
• To highlight how these networks can integrate trials into routine clinical practice.
• To align with the FDA's goals for advancing a learning health system.

Main Methods:

• This is an invited commentary, not an empirical study.
• Discussion focuses on the capabilities and potential applications of PCORnet.
• Analysis of how network infrastructure can support streamlined trial execution.

Main Results:

• PCORnet and similar networks offer a framework for efficient evidence generation.
• These networks can enable the integration of clinical trials into standard care.
• Streamlined trials in the postmarket setting can be facilitated by national networks.

Conclusions:

• National networks like PCORnet are vital for accelerating progress towards a learning health system.
• Streamlined clinical trials integrated into practice can enhance evidence generation.
• Collaboration between research networks and regulatory bodies is key to advancing healthcare research.