What is the Tufts CTSI Pilot Studies Program?

The Tufts CTSI Pilot Studies Program is a funding opportunity supported by the National Center for Advancing Translational Sciences (NCATS) – one of 27 Institutes and Centers at the National Institutes of Health (NIH). The program provides one-year awards to individual investigators and research teams at Tufts CTSI-affiliated academic, medical, industry, not-for-profit, and community partner and collaborator institutions. It aims to improve population health by supporting innovative, interdisciplinary, high impact, translational science projects that will allow investigators to develop and disseminate novel tools or methods and/or to generate sufficient preliminary data for a larger follow-on study. Applicants are expected to have a defined plan for the publication and dissemination of all research results and for seeking future extramural funding as well as an integrated strategy for engaging relevant stakeholders to support collective action for health improvement.

What is translational science?

NCATS defines translation as “the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and populations – from diagnostics and therapeutics to medical procedures and behavioral interventions.” The translational science spectrum is generally divided into four interconnected stages, with each stage building upon and informing the others. The spectrum includes translation of basic biomedical research into demonstrated effects for patients or from bench to bedside (T1), from bedside to practice (T2), from clinical practice to widespread clinical practice and care delivery (T3), and from widespread clinical care delivery to new health policies aimed at improving public’s health (T4). Tufts CTSI also recognizes a critical phase which cycles between “basic” research and early clinical investigation (T1), which we call T.5 research. This bidirectional, nonlinear phase helps improve translational potential of basic biomedical discoveries and prototypes, bridging the pre-clinical development to initial human studies. Learn more about translational science and the translational spectrum for Tufts CTSI here.

Does Tufts CTSI fund basic research?

No. Basic research (earlier than T.5), while a critically important foundation for translational research, is not part of the translational spectrum and focuses on gaining greater knowledge and understanding of the fundamental mechanisms of biology, disease, or behavior. Basic research identifies opportunities and potential approaches to health problems and includes a broad range of approaches employing animal models of human disease, research in tissue culture cell lines, computational models, human physiological studies, and non-interventional, correlational epidemiologic studies. Basic research yields knowledge about basic biological, social, and behavioral mechanisms and presentations of human disease.

What awards are granted?

The Pilot Studies Program funds projects that provide generalizable insights to advance cutting-edge prevention practices, facilitate translation of new treatments and cures for disease into clinical care, and increase the overall effectiveness and quality of health care – thereby improving the health and wellbeing of the public. To help address existing translational roadblocks, the program supports research projects across the full translational spectrum. In addition, the program prioritizes pilot translational research projects in one or more areas of: (1) Comparative Effectiveness Research that compares the benefits and harms of alternative interventions, including improving health care delivery to prevent, diagnose, monitor, or treat a clinical condition; (2) Methods Development that supports the development of new, generalizable, and broadly-applicable procedures, techniques, and tools for approaching and solving translational research questions, problems, or barriers; and/or (3) One Health approaches that promote integrative solutions for medical issues by incorporating expertise from diverse fields that study the health of humans, animals, and the environment.

Who is eligible to apply?

Principal Investigators (PIs) must have a primary appointment or position at a Tufts CTSI academic, medical, industry, not-for-profit, and community partner and collaborator institution and be eligible to receive NIH funding. Research teams may include other key personnel who contribute to the scientific development and execution of a project in a substantive, measurable way. All PIs and Co-PIs (Multiple PIs) are required to have an Electronic Research Administration (eRA) Commons username. If the proposed project is funded, other budgeted key personnel will be required to have their eRA Commons usernames as well. These usernames may be obtained from the research administration office of the investigator’s organization. To see a list of eligible partner and collaborator institutions, please click here.

If I previously received a Tufts CTSI Pilot Studies Program grant, may I apply again?

Yes, you may apply again. However, your funding request must be for a new project only; a follow-on project previously supported through the program will not be considered. If you have served as a PI or a Co-PI (Multiple PI) on two Tufts CTSI pilot awards, you will not be eligible to apply as key personnel for another award until five years from the end date of your last award. For example, a PI who received a second pilot award that ended in 2015 will not be eligible to re-apply as a PI or Co-PI (Multiple PI) until 2020. To be considered for new funding, you must comply with all prior award reporting requirements. Failure to report study outcomes may preclude you or your research team members from being eligible for new Tufts CTSI funding.

What is the expected duration of the 2019 Pilot Studies Program award?

Selected Tufts CTSI Pilot Studies Program projects will be funded for one year, beginning May 1, 2019 and ending April 30, 2020, pending NIH approval. Please make sure to review all post-award procedures and requirements.

What are the different types of funding levels?

Awards will be made to individual investigators and research teams from Tufts CTSI partner and collaborator institutions for up to $30,000 per award. In order to stimulate collaboration, Tufts CTSI will also consider funding multi-site research projects led by investigators from up to three Tufts CTSI-affiliated institutions with an incremental budget allocation up to $15,000 per additional institution. For example, research teams including collaborators from two Tufts CTSI-affiliated institutions could request a total budget of up to $45,000 and research teams including collaborators from three Tufts CTSI-affiliated institutions could request a total budget of up to a maximum award amount of $60,000. Funds for multi-site research projects may be allocated across sites in accordance with project needs. Please note that Tufts CTSI-affiliated for-profit organizations are eligible as sites, but they may not receive funding.

What qualifies as a “multi-site research project”?

Applicants seeking funding for a multi-site research project must include research team members with primary appointments or positions at two or three Tufts CTSI-affiliated institutions. Each site must designate a contact PI responsible for the scientific development and execution of a project. Research teams may include other personnel at each site including investigators from the basic, clinical, and/or applied science. Members of multi-site research teams must meet all Tufts CTSI Pilot Studies Program eligibility requirements. Please note that the schools and centers of Tufts University are considered one site for the purposes of this program. For example, if your project includes Tufts University School of Medicine and Tufts University School of Engineering, both schools count as one site, not two.

Can my research team include collaborators who are not affiliated with Tufts CTSI?

Yes, research teams may include collaborators from institutions not affiliated with Tufts CTSI and/or who do not have primary appointments or positions at Tufts CTSI-affiliated institutions. However, such collaborators may not receive funding and will not be considered a site for a multi-site proposal.

Are there any budget restrictions or limitations?

Applicants may request funds for direct costs only. Allowable budget expenses include investigator and support staff salary and fringe benefits; clinical support; laboratory research supplies; and biostatistical or biomedical informatics services. Salary support for existing personnel must be justified and include a description of past support and plans for future support after the Tufts CTSI pilot is completed. In most cases, unallowable costs include:

  • General office supplies and expenses, telephone, data plans, internet, etc.
  • Clinical equipment
  • Computers, laptops, other electronics (unless specifically required and justified – if approved, must be purchased within the first 90 days of project, and be returned to Tufts CTSI at the end of the approved project period)
  • Graduate program tuition, stipends, or fees
  • Meals or hospitality (including alcohol)
  • Membership dues, professional fees, rent
  • Postage and mail
  • Budget over-expenditures
  • Other items generally considered “facilities and administrative” expenses

What is the application process for Pilot Studies Program grants?

Unless announced otherwise, the request for applications is issued on an annual basis in the late summer/early fall of each calendar year. The program has a two-phase application process that includes a brief letter of intent and a final application. Letters of intent are required for all applicants. Those submitting a letter of intent will receive a link to the application and instructions via email. All applications will be peer-reviewed for quality and, if applicable, fit with Tufts CTSI’s priority research areas. Please see the timeline below for submission deadlines and other important dates.

  • Letter of intent submission period begins: Monday, September 24, 2018
  • Letter of intent due: Monday, October 15, 2018
  • Application available: Monday, October 29, 2018
  • Final application due: Monday, December 3, 2018
  • Awards announcement: mid-January 2019

May I submit two or more pilot project ideas?

Yes. Provided that you meet the eligibility requirements, you may submit more than one letter of intent. While we do not have a set limit on the number of idea submissions, we encourage you and your research team to prioritize quality over quantity.

How will I know if my letter of intent got approved?

The letters of intent are used only to assess applicant eligibility, and to begin collaborative project development, protocol development, and budget discussions. Unless you are otherwise notified by Tufts CTSI, if you successfully submit a letter of intent, you will be eligible to submit a complete application.

How will my application be reviewed?

All applications will be reviewed following modified NIH guidelines for peer review by the Tufts CTSI Pilot Studies Program Scientific Training and Review Committee, which is comprised of past pilot awardees and other investigators from Tufts CTSI partner and collaborator institutions. Each application will be assigned at least two peer-reviewers with relevant expertise. Key scientific review criteria include: ability to advance translational interdisciplinary research, significance and scientific rigor of the proposed pilot project, potential to shift current research or clinical practice paradigms by using novel approaches, qualifications of the research team, likelihood of meeting proposed objectives and goals, and clear articulation of next steps (e.g., plans and timeline for publishing research results and seeking future extramural funding). In addition, when applicable, top-scoring applications will be reviewed by Tufts CTSI Program Leaders for relevance to priority research areas identified by Tufts CTSI.

May I apply simultaneously for a KL2 Career Development Award Program grant and a Pilot Studies Program grant?

Yes. A single PI or a Co-PI (Multiple PI) may submit both a KL2 and a pilot application. These two applications will be reviewed and scored independently by separate review committees. Please note, however, a PI or a Co-PI (Multiple PI) cannot be awarded a simultaneous KL2 and Pilot Studies Program award. If an investigator has a KL2 award, he or she may only serve as a Co-I of Pilot Studies Program application. This pilot study must be a different research project than that proposed for the KL2 award program.

Does Tufts CTSI offer any assistance with project design and planning?

Tufts CTSI offers an array of pre-award research services at no cost to investigators with primary appointments or positions at Tufts CTSI partner or collaborator institutions. We provide methodological and technical consultations, study design support, connections to collaborators and relevant stakeholders, and guidance on project planning and process improvement. In addition, we assist applicants with proposal preparation and submission, including meeting all eligibility, multi-site team, and funding requirements, and responding to Tufts CTSI funding priority areas. We strongly encourage applicants to use these valuable services prior to submitting a letter of intent and/or during the proposal development phase. Request a consultation here.

Where can I find a list of pilot awardees from prior years?

To see a list of past recipients and their project titles, please click here.

Where can I learn more about stakeholder and community-engaged research?

View this conversation with Drs. Jonathan Garlick and Thomas Concannon about how T1/basic researchers can use Stakeholder and Community Engagement to strengthen their research teams and impact population health (full version and highlights):

 

Whom can I contact with additional questions?

If you have any questions related to the program, please contact the Pilot Studies Program team at pilots@tuftsctsi.org.

To request an in-person or virtual consultation, please submit a service request.