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NOT-TR-21-022 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for the Clinical and Translational Science Award (CTSA) Program to Address COVID-19 Public Health Needs

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH), intends to issue a sole source emergency competitive revision award. NCATS plans to issue a sole source award in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID 19). In order to respond to the public health emergency, NCATS and the Patient-Centered Outcomes Research Institute (PCORI) have executed a Memorandum of Understanding [ACTIV-6 Clinical Trial Initiative to Test Approved Drugs for the Treatment of COVID-19 Infections in Non-Hospitalized Patients Using the PCORnet® Infrastructure (ACTIV-6 Clinical Trial Initiative)] to collaborate to support the ACTIV-6 platform study of COVID-19 therapeutics by using existing infrastructure to implement the project. This undertaking requires an entity that is positioned and ready to fulfill all the requirements to conduct this large, complex, highly collaborative project.

The following requirements must be met by the recipient who must immediately implement the ACTIV-6 platform study:

• Already has an established relationship with both parties to the MOU, PCORI and NCATS
• Already has an existing relationship with a network of clinics that are actively conducting clinical studies and that are in both traditional academic centers and community settings; the ACTIV trials already funded have utilized existing networks as much as possible to launch trials quickly
• Has demonstrated the ability to quickly identify and add other sites as needed, particularly as the number of COVID-19 cases declines in the United States and competing COVID-19 therapeutic trials at institutions increase the need for additional sites
• Has significant experience managing large, multicenter (60+ sites) clinical trials and many available experienced clinical research staff to support trial operations. ACTIV-1, ACTIV-2 and ACTIV-3 each plan to have 75 to 95 sites to enroll a sufficient number of participants to answer the study questions
• Has demonstrated the ability to collect data remotely as needed and utilize electronic health records to collect study data. One goal of ACTIV-6 is to leverage electronic health records as much as possible to collect study outcomes
• Has extensive experience working with non-domestic sites if it becomes necessary to expand to other countries to complete ACTIV-6.

Duke University serves as the Coordinating Center for the well-established PCORI-funded PCORnet®, the National Patient-Centered Outcomes Research Network, which is a network of networks that constitute a robust research ecosystem that includes a fully integrated network where vast, highly representative health data, research expertise, and patient insights are built-in and accessible.

In addition, Duke University is one of the longstanding NCATS-funded CTSA Trial Innovation Centers, which, together with the CTSA Hubs and Recruitment Innovation Center comprise the CTSA Trial Innovation Network (TIN). The CTSA TIN focuses on operational innovation, operational excellence and collaboration while leveraging the expertise, diversity and broad reach of the CTSA Program.

Therefore, because no other entity can immediately meet all of the requirements delineated above for implementing the ACTIV-6 platform study, NCATS intends to issue a sole source competitive revision (supplement) award to Duke University, Durham, NC. This award will provide the Government the opportunity to save time and financial resources needed to expedite this collaborative project. With over 500,000 lives lost to the pandemic to date, start-up for the ACTIV-6 platform study is critical and only one organization is positioned to launch this study as soon as April 2021.

This is not a solicitation for applications. However, the application for the sole source award must be submitted to NOT-TR-21-022: Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for the Clinical and Translational Science Award (CTSA) Program to Address COVID-19 Public Health Needs (nih.gov).

Inquiries

Please direct all inquiries to:

Stacia Fleisher, MPP
National Center for Advancing Translational Research (NCATS)
Phone: 301-435-0851
Email: stacia.fleisher@nih.gov