The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies

Area of Science:

• Clinical Diagnostics
• Public Health Preparedness
• Infectious Disease Research

Background:

• The COVID-19 pandemic necessitated rapid development of diagnostic tests.
• Existing diagnostic development timelines are often lengthy and costly.
• The National Institutes of Health (NIH) established the Rapid Acceleration of Diagnostics (RADx) Tech initiative to expedite this process.

Purpose of the Study:

• To outline the structure and function of the Clinical Studies Core (CSC) within the RADx Tech initiative.
• To detail the CSC's role in supporting the development and commercialization of SARS-CoV-2 point-of-care tests.
• To highlight the CSC's contribution to diverse population and setting-based device studies.

Main Methods:

• Development of a robust clinical study infrastructure in under several months.
• Implementation of a master protocol, digital study platform, and data management system.
• Establishment of a single Institutional Review Board (IRB) and multi-site partnerships for efficient study execution.

Main Results:

• Successful development of infrastructure enabling rapid SARS-CoV-2 device studies.
• Data generated are supporting Emergency Use Authorization applications for novel diagnostic tests.
• Demonstrated reduction in typical medical device development time and cost.

Conclusions:

• The CSC effectively accelerated the development and deployment of critical diagnostic tools.
• Academic and NIH partnerships proved vital for addressing urgent public health needs during a pandemic.
• The CSC's model offers valuable lessons for future in vitro diagnostic device clinical studies.