The NC TraCS Clinical and Translational Science (CTS) Pilot Program supports investigation focused on understanding the scientific and operational principles underlying each step of the translational process, so that advances can be applied to research on any target or disease.

Clinical and Translational Science (CTS) Pilot Program

We are seeking proposals that focus on understanding a scientific or operational principle underlying a step of the translational research process with the goal of developing generalizable principles to accelerate translation.

CTS Program

The NC TraCS Clinical and Translational Science (CTS) Pilot Program supports investigation focused on understanding the scientific and operational principles underlying each step of the translational process, so that advances can be applied to research on any target or disease.

Projects must be feasible within the proposed one-year timeframe, have high methodological and scientific quality.

Access the slides from the information sessions held September 2022:

TraCS CTS Pilot educational session 2022 (pdf)

Translational Science

The National Center for the Advancement of Translational Science (NCATS) defines Translational Science as "the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process."

Whereas translational research focuses on the specific case of a target or disease, translational science is focused on the general case that applies to any target or disease.

A key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects (e.g., incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability, ineffective clinical trial recruitment).


Program Overview

The TraCS Clinical and Translational Science (CTS) pilot award program is intended to support Clinical and Translational Science (CTS), the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.

Projects are 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 in CTS; and
  3. provide initial support to establish proof of concept.

Projects must be feasible within the proposed timeframe, have high methodological and scientific quality, and answer important scientific questions. Pilot project support is not intended for large projects by established investigators that would otherwise be submitted as separate research grant applications.

What is Translational Science versus Translational Research?

Whereas translational research focuses on the specific case of a target or disease, translational science focuses on the general case that can be applied to research on any target or disease. The below example illustrates the distinction between Translational Research and Translational Science.

Translational Research (TR)

The endeavor to traverse a particular step of the translational process for a particular target or disease

  • An investigator wishes to test whether a particular drug improves outcomes in patients with type 2 diabetes.
  • The study team proposes to recruit sufficient underserved participants into the trial to ensure that study results are relevant to populations that have greater disease burden.
  • This is a Translational Research problem and will be addressed from the standpoint of effectiveness of the drug and the diabetes community, using established recruitment methods.

Translational Science (TS)

The field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process

  • Recognizing that underrepresentation of minority populations in clinical studies is a significant and ongoing concern, an investigator wishes to understand the fundamental underlying barriers to recruitment for clinical trials generally and test an intervention to address those hypothesized causes and mechanisms.
  • Because the findings of this work would have application across a broad range of studies, this work would be considered Translational Science (TS). However, to test the hypothesis and demonstrate the efficacy of the intervention, the TS investigator may use the previously described diabetes drug study as a use case.
  • The primary question is whether the TS innovation accomplishes full recruitment of the desired underserved population more effectively and efficiently.

Source: grants.nih.gov/grants/guide/pa-files/PAR-21-293.html

Applications submitted to the TraCS CTS Pilot Program must focus on translational science ; translational research projects are generally not allowed. However, the proposed research may use a specific use case to test a CTS hypothesis (see above), in which case the CTS relevance of the work should be clearly described.

Examples of CTS topics

Types of pilot activities that may be supported include the following. Note that these are examples, not an exhaustive or complete list:

  • Development of new research methodologies and/or new technologies/tools/resources that will advance CTS and thus increase the efficiency and effectiveness of translation
  • Development of strategies to increase inclusion of understudied populations
  • Early-stage development of new therapies/technologies with generalizable application to an identified translational roadblock
  • Demonstration, 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
  • Secondary analysis of existing data (e.g., projects using the National COVID Cohort Collaborative (N3C) Data Enclave)

Here are some specific examples of translational pilot project topics with CTS application:

1. Identifying barriers to participation in prospective autism infant sibling research for Black families: a qualitative and quantitative approach

This project proposed to:

  1. Explore individual, family, and systems-level barriers to recruitment and retention of Black families in autism infant sibling research,
  2. Identify the most significant factors that predict recruitment and retention of Black families into autism infant sibling research through a novel, data-driven, machine learning algorithm, and
  3. Disseminate recommendations and solutions identified through Aims 1 and 2 to a nationwide network of scientific experts and stakeholders in the autism field.

This project has CTS application since the goal is to improve recruitment methods using Autism as the use case.

2. Non-invasive optoelectronic systems for diabetes health monitoring at the skin interface

This project describes the development of an advanced wireless, noninvasive, wearable glucose sensor, integrating optical polarimetry, near-infrared spectroscopy in a soft, patchable, and miniaturized construction, that incorporates a novel multi-modality sensing algorithm for enhanced accuracy and stability.

While the use care here is specific to diabetes, these technologies may, if successful, be applicable to other use cases.

3. Validating Claims-based Definitions for Deprescribing Using Electronic Health Records: Bridging the Gap Between Clinical and Administrative Data Sources

The goal of this study is to better understand and improve claims-based deprescribing definitions by comparing claims with detailed EHR data. It focuses on a clinical scenario in which deprescribing is clearly indicated—benzodiazepine use following a fall-related hospitalization in older adults. Comparing claims data to unstructured EHR data will enable assessment of when a patient's medication was deprescribed, and how well gaps in medication use in claims data can identify intentional deprescribing and distinguish it from stoppages for other reasons (e.g., patient nonadherence). The results of this study will provide pilot data for a larger study that will help better implement deprescribing interventions by study patterns and outcomes of deprescribing of various medication types.

Using benzodiazepine deprescription as a use case, this is designed to be an improvement on an important data tool used in all sorts of research.

Translational Science Roadblocks

A list of common roadblocks to clinical and translational science:
TraCS CTS Pilot Roadblocks Table (pdf)

Funding

For each annual CTS pilot grant cycle, NC TraCS will award up to eight (8) grants of $25,000 – $50,000 direct costs. Awards are to be expended within a 12-month period starting from the date of issue of a Notice of Award. Budget details and procedures, including allowed expenses, are detailed in the Application Instructions.

Key Dates
FOA Release Date September 6, 2022
FAQ Sessions September 20, 2022 (Tue) @ 2 p.m.
September 29, 2022 (Thu) @ 10 a.m.
Concept Proposal (REQUIRED) Due Date October 11, 2022
Invitation for Full Proposals issued by October 25, 2022
Consultation with NC TraCS* Between October 25 - December 7
Full Proposal Due Date January 10, 2023
Anticipated Funding Announcement February 14, 2023
Anticipated Funding Start April 3, 2023

* All applicants are strongly encouraged to consult with pilot program staff prior to submitting a full proposal, to ensure optimal responsiveness to the FOA. However, applicants proposing to use TraCS services are required to meet with pilot program staff prior to submitting a full proposal.

Applicant Eligibility
  • Researchers from any of NC TraCS' partner institutions (UNC-Chapel Hill, N.C. A&T, NC State) can serve as Principal Investigator (PI) of a CTS pilot grant. Eligible PIs should hold a permanent faculty appointment or a non-faculty appointment, such as "research scientist" or other position typically held by investigators from research institutes and centers who are eligible to apply for investigator-initiated external awards, such as NIH "R" funding. For specific questions regarding eligibility, contact This email address is being protected from spambots. You need JavaScript enabled to view it..
  • Multiple-PI teams, multi-institutional teams and multi-disciplinary teams are encouraged. Team size and expertise should be appropriate for the work proposed in the grant application.
  • Where a multiple-PI leadership structure is proposed, one PI must be designated as the "Contact PI", the PI who will serve as the primary contact between the research team and CTS Pilot Program administration.
Application Instructions and FAQ
Questions/Contacts
  • Questions regarding applicant eligibility may be directed by email to This email address is being protected from spambots. You need JavaScript enabled to view it., Director, TraCS Innovations Program.
  • Questions regarding the application process may be directed by email to This email address is being protected from spambots. You need JavaScript enabled to view it., TraCS Director of Research Development.
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