Challenges in Use of Practice-based Research Networks for a Medical Device Trial to Detect SARS-CoV-2

Area of Science:

• Clinical Research
• Public Health
• Biotechnology

Background:

• Primary care practice-based research networks (PBRNs) are crucial for real-world clinical research.
• Point-of-care (POC) diagnostic devices accelerate disease detection and management.
• The National Institutes of Health (NIH) funded a study to advance POC SARS-CoV-2 testing.

Purpose of the Study:

• To characterize participating PBRNs and collaborators in a SARS-CoV-2 POC device trial.
• To identify and describe challenges encountered during the execution of the device study within PBRNs.

Main Methods:

• Semi-structured interviews were conducted with key personnel from participating PBRNs and the lead academic institution (UMass Chan Medical School).

Main Results:

• Three out of four invited PBRNs participated, alongside UMass.
• The trial enrolled 321 subjects in six months, with PBRNs contributing 65 subjects.
• Key challenges included insufficient clinic personnel, evolving inclusion/exclusion criteria, data collection platform issues, and lack of specialized equipment (e.g., -80°C freezer).

Conclusions:

• PBRN participation in device studies is resource-intensive and faces significant operational hurdles.
• Future device studies should proactively address potential recruitment criterion changes, equipment needs, and study continuity to better support PBRN practices.