OVERVIEW of the CTS Pilot Studies Program:

 

Details of the CTS Pilot Studies Program can be found here. The iTHRIV CTS Pilot Studies Program is a core component of the NIH-funded Clinical and Translational Sciences Award (CTSA). iTHRIV is a cross-state collaborative research network with a mission of using data to improve health. iTHRIV participating institutions include: Carilion Clinic (CC), the Center for Open Science (COS), the Virginia Cooperative Extension (VCE), the Virginia Department of Health (VDH), the University of Virginia (UVA), and Virginia Tech (VT).

 

By providing early-stage pilot funding, the iTHRIV CTS Pilot Studies Program aims to develop innovative approaches to translational science (TS) projects, and foster collaboration across iTHRIV institutions. 

 

TS seeks to understand the scientific and operational principles underlying the translational research process. TS is focused on the general case that applies to any target or disease (see examples of TS projects below). Translational research (TR) projects solely focused on a particular target or disease are not allowed. To learn more about TS, please see this Learning Short video and this brief video.

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The CTS Pilot Studies Program is intended to (1) explore possible innovative new leads or new directions for established investigators; (2) stimulate investigators from other areas to lend their expertise in research to CTS; and (3) provide initial support to establish proof of concept.

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Examples of TS projects may include, but are not limited to:

• Development of new research methodology and/or new technologies/tools/resources that will advance CTS and thus increase the efficiency and effectiveness of translation.

• Early-stage development of new therapy/technology with generalizable application to an identified translational roadblock.

• Demonstrate in a particular use case(s) that the new methodology or technology advances translational science by successfully making one or more steps of the translational process more effective or efficient.

• Dissemination of effective tools, methods, processes, and training paradigms.

• Feasibility/proof of concept studies to support future CTS projects.

• Development of educational or training modules advancing the science of translation.

• Development of tools/technology/strategies to overcome barriers to research including barriers to study enrollment.

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Eligibility for CTS Pilot Program reviewers

• Investigators who are eligible to serve as a Principal Investigator on external grants and contracts at one of the participating iTHRIV institutions can serve as reviewers.

• Experience as a reviewer for NIH-supported research is preferred.

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Please note

• Signing up does not commit you to be the reviewer, it just means that you will be in a pool of potential reviewers.

• Signing up does not guarantee that you will be selected as a reviewer for this funding cycle.

• Selected reviewers are expected to review 1-3 applications, depending on the volume of applications received and with mutual agreement.

• Attendance at one virtual study section meeting (~90 min; early August 2025) is expected, but not required.

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Guidelines for the reviewers

• Identify the most promising TS projects for funding. Preferences will be given to applications:

  •  judged to have a high potential for leading to subsequent external funding;

  • that plan to address a challenge in the translational science process; and

  • with team science collaborations across two or more iTHRIV institutions.

• ·Declare potential conflicts of interest (see Managing Conflict of Interest in the Peer Review Process)

• Maintain the confidentiality of peer review information

• Review assigned applications and provide numeric scores using provided rubric.

• Prepare a written critique for each application with recommendations concerning the scientific and technical merit of applications under review

• Make recommendations concerning protections for human subjects; inclusion of women, minorities, and children in clinical research; welfare of vertebrate animals; and other areas as applicable for the application

• Make recommendations concerning appropriateness of budget requests

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Managing Conflicts of Interests in the Peer Review Process

• Proposed reviewer may not participate on the study section if:

  • The reviewer is named on any iTHRIV CTS pilot application in a major professional role

  • The reviewer (or close family member) would receive a direct financial benefit if the application is funded

• Proposed reviewer may participate on the study section but may not review certain applications if:

  • Within the past three years, the reviewer has collaborated with, been involved in the preparation of a grant application or contract proposal with, or had any other professional relationship (e.g., served as a mentor) with a PI of the application.

  • The reviewer provided a letter of support or reference letter for the application under review.

  • The reviewer serves as a member of the advisory board for the application under review.

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Timeline (Anticipated)

The following timelines are estimates and subject to change.