View the slides from the 2022 Tufts CTSI Pilot Studies Program Information Session Webinars (PDF).

Watch the video from the 2022 Tufts CTSI Pilot Studies Program Information Session Webinars (mp4).

Overview

The Tufts Clinical and Translational Science Institute (CTSI) Pilot Studies Program seeks proposals for innovative, high-impact, translational science projects with a focus on building interdisciplinary, multi-institutional research teams. The program aims to improve population health by funding new 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. Successful pilot projects should address a research question that provides generalizable insights to help advance cutting-edge prevention practices, support translation of new treatments and cures for disease into clinical care, and increase the overall effectiveness and quality of health care and public health interventions – thereby improving the health and well-being of the public.

All applicants should have a preliminary hypothesis underlying the research and a defined plan and timeline for the publication and dissemination of all research results and for seeking future extramural funding. In support of collective action for health improvement, they should also have an integrated strategy for engaging stakeholders relevant to their proposed projects. Stakeholder engagement should be broadly-conceived to support inclusion in one or more parts of the research process.

In addition to individuals at Tufts University and Tufts Medical Center, eligible applicants include members of Tufts CTSI partner or collaborator institutions. Individuals and research teams may request up to $40,000 per award. To stimulate collaboration, research teams including investigators from multiple Tufts CTSI-affiliated institutions may request up to $55,000 per award. Selected projects will be funded for one year, beginning May 1, 2022 and ending April 30, 2023, pending National Institutes of Health (NIH) approval.

Who is eligible?

To be eligible for the Pilot Studies Program grant, the Principal Investigator (PI) must have a primary appointment or position at a Tufts CTSI academic, medical, not-for-profit, or community partner or collaborator organization. Applicant research teams may include collaborators who are and who are not affiliated with Tufts CTSI.

Request for Applications

The Tufts CTSI Pilot Studies Program seeks proposals for innovative, high-impact, translational science projects with a focus on building interdisciplinary, multi-institutional research teams. The program has a competitive two-step application process that involves an initial submission of a Letter of Intent (LOI), due on Thursday, September 30, 2021, and, if invited, a full proposal, due on Monday, December 13, 2021.

Key Dates

  • Letter of intent submission period begins: Wednesday, September 1, 2021
  • Information webinars and Q&A sessions: Thursday, September 9, 2021 at 8:30AM and Monday, September 13, 2021 at 4:00PM (email pilots@tuftsctsi.org to register)
  • Competitive Letter of Intent due: Thursday, September 30, 2021 at 11:59 PM
  • Invitation to submit full proposal: by Monday, November 1, 2021
  • Proposal due: Monday, December 13, 2021 at 11:59 PM (by invitation only)
  • Award announcement: February 2022

New This Year – Competitive Letter of Intent (LOI)

The 2022 Pilot Studies Program will accept full proposals by invitation only. To be considered, all applicants are required to submit a competitive LOI presenting a concise and thought-out description (up to three pages in length) of their ultimate proposal. The LOI should describe the project and its proposed methods of study in adequate detail so that their merit may be assessed. All compete LOIs will be peer-reviewed by at least two scientific reviewers for their alignment with the program objectives, translational relevance, scientific rationale and rigor, feasibility, potential for impact, and clarity. Projects invited to submit a full proposal will be selected with input, as appropriate, from the Tufts CTSI Biostatistics, Epidemiology, and Research Design (BERD) Center, Research Collaboration Team, Evaluation and Continuous Improvement, Stakeholder and Community Engagement, and Integrating Underrepresented Populations in Research Programs. All LOI applicants will be notified, whether or not their projects are chosen to move forward to the proposal stage and provided a summary of the reviewer comments.

View LOI instructions, download templates, and apply here.

About the Program

The Pilot Studies Program is a funding opportunity supported by the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). It provides one-year awards in support of new translational science projects that have the potential to answer important questions and/or that address translational roadblocks. The program is intended to allow investigators to develop and disseminate novel tools or methods and/or to generate sufficient preliminary data for a larger study. It prioritizes actionable research that improves health outcomes of the community and advances health equity for traditionally marginalized, underserved, and underrepresented populations. Consistent with the NCATS mission and local priorities, the program funds translational and clinical research across the full translational spectrum (T.5 to T4) rather than basic discovery research.

All applicants should have a preliminary hypothesis underlying the research and a defined plan and timeline for the publication and dissemination of all research results and for seeking future extramural funding. In support of collective action for health improvement, they should also have an integrated strategy for engaging stakeholders relevant to their proposed projects. Stakeholder engagement should be broadly conceived to support inclusion in one or more parts of the research process.

Successful pilot projects should address a research question that provides generalizable insights to help advance cutting-edge prevention practices, support translation of new treatments and cures for disease into clinical care, and increase the overall effectiveness and quality of health care and public health interventions. They should strive to promote health equity to help improve the health and well-being of diverse populations, especially those who disproportionately experience persistent disparities.

Applicant Eligibility

Applications must designate a Principal Investigator (PI) with a primary appointment or position at a Tufts CTSI partner or collaborator organization. Research teams may include other key personnel, including those not affiliated with Tufts CTSI. Proposed pilot studies should be innovative and have no current funding or only modest intramural or extramural support that will be enhanced by the pilot activities.

Project Eligibility

Applicants must propose projects that are translational in nature. Although they are critically important, basic discovery research projects, such as those that yield knowledge about basic biological, social, and behavioral mechanisms and presentations of human disease, are not eligible. If proposed, clinical trial activities must not go beyond the end of Phase IIB.

Award Period and Project Start Requirements

Selected projects will be funded for one year from May 1, 2022 through April 30, 2023. Project start and release of funds will be contingent upon receipt of all applicable local institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) approvals and/or exclusion determination letters. In addition, projects involving human and/or animal subjects as well as projects involving a foreign component, regardless of their study type, are required to comply with any and all applicable NCATS prior approval requirements.

Award Amounts

Awards will be made to eligible individuals or research teams for up to $40,000 per award. To stimulate collaboration, research teams including investigators from two or more Tufts CTSI-affiliated organizations may request up to $55,000 per award. Funds may only be used to cover direct costs that are necessary and reasonable to complete the proposed research project. For multi-site projects, funds may be allocated across sites in accordance with project needs.

Complementary In-kind Support

In addition to direct funding, award recipients will be provided access to a robust array of complementary research resources and services as well as publication support.

  • Research Resources and Services: Award recipients will be provided ongoing pre- and post-award scientific and logistical support to help address translational roadblocks that may arise. It will be offered by a support team co-led by Tufts CTSI research-active clinical faculty and staff.
  • Publication Support: Tufts CTSI will make funding available for journal fees, including publication processing and open access charges. Award recipients may request such support for one eligible publication per research project.
  • The Tufts CTSI Clinical and Translational Research Center (CTRC) Support: Applicants and co-applicants with a primary position or faculty appointment at Tufts Medical Center (Tufts MC) or Tufts University (TU) may leverage the Tufts CTSI CTRC Voucher Program for an additional $5,000 of in-kind clinical research services. Eligible applicants may request such support (e.g., routine and specialized nursing, sample collection and processing, study coordination, regulatory assistance, medical administration, and use of clinical facilities and equipment) as part of their Pilot Studies Program application.

Eligibility Information

Principal Investigator

Eligible applicants include members of Tufts CTSI-affiliated organizations, which span academic partners, affiliated hospitals, for-profit and not-for-profit collaborators, and community-based organizations. PIs must have a primary appointment or position at a Tufts CTSI partner or collaborator organization.

Eligible Sites

Academic Partners and Collaborators

(PLEASE NOTE: all schools and centers of each academic partner are considered one site)

  • Brandeis University
  • Massachusetts General Hospital Institute of Health Professions
  • Massachusetts Institute of Technology
  • Northeastern University
  • RAND Corporation
  • The Jackson Laboratory
  • Tufts University
Clinical Partners and Collaborators
  • Baystate Medical Center
  • Lahey Hospital and Medical Center
  • Maine Medical Center
  • Newton-Wellesley Hospital
  • Elizabeth’s Medical Center
  • Tufts Medical Center
For-profit and Not-for-profit Partners and Collaborators

(PLEASE NOTE: for-profit organization are eligible as participant sites, but they cannot receive funding)

  • Blue Cross Blue Shield of Massachusetts
  • Massachusetts Biotechnology Council
  • Massachusetts Biotechnology Education Foundation
  • Novartis
  • Pfizer, Inc.
  • Tufts Health Plan
Community Partners and Collaborators
  • Action for Boston Community Development
  • Asian Community Development Corporation
  • Asian Task Force Against Domestic Violence
  • Asian Women for Health
  • Boston Chinatown Neighborhood Center
  • Center for Information and Study on Clinical Research Participation
  • Greater Boston Chinese Golden Age Center
  • Health Resources in Action
  • Museum of Science, Boston
  • New England Quality Care Alliance

Multi-Site Research Teams

Members of multi-site research teams must meet all Pilot Studies Program eligibility requirements. Each site of a multi-site research project must designate an investigator with a primary appointment or position at a Tufts CTSI partner or collaborator organization who will serve as a lead contact at that site. Research teams may also include collaborators who are not affiliated with Tufts CTSI. Provided their involvement is necessary for the conduct of the project, applicants may earmark part of their budget for collaborator-supported research activities.

Translational Science Spectrum

To be invited to submit a full proposal, applicants must propose projects that advance clinical and translational research along the T.5-T4 translational spectrum. As applicable, they must demonstrate an explicit, well-defined, and easily foreseeable purpose of delivering effective and impactful health care interventions.

  • T.5 – Bridging Pre-clinical Development to Initial Human Studies: T.5 research focuses on the transformation of concepts and testable prototypes, be they devices, diagnostics, drugs, or data algorithms, into impact on clinical care and health, and yields knowledge to improve translational potential of basic biomedical discoveries and prototypes.
  • T1 – From Bench to Bedside: T1 research translates promising laboratory and pre-clinical findings into the care of patients (e.g., testing a treatment or preventive measure in humans, testing a diagnostic assay or strategy, proof-of-concept and first testing in humans for promising physiology, toxicity, pharmacokinetics treatments, and other preliminary efficacy studies, as well as evaluation of novel methods of diagnosis).
  • T2 – From Bedside to Clinical Practice: T2 research translates successful applications in humans into wider use in widespread clinical practice, into patient populations, and includes controlled observational studies and clinical trials, survey research, and other approaches to further define the appropriateness of treatments and tests in clinical care.
  • T3 – From Clinical Practice to Widespread Clinical Practice and Care Delivery: T3 addresses the need to understand whether treatments, diagnostic tests, or other interventions are generalizable to the wider span of clinical practice.
  • T4 – From Health Care Delivery to Impact on the Community, on the Public’s Health, and on Public Policy: T4 research translates effective health care delivery into improved community and population health, informs new policies, and includes interventions in, and monitoring of, populations, the wider dissemination and/or implementation of improved practices/interventions, and health policy.

Foreign Component

Applicants proposing research involving a foreign component, as defined by NIH, are eligible to apply. However, they must provide a compelling justification for such research and/or involvement of a foreign component (e.g., performing a specific element or segment of a project outside of the U.S., with assistance of a collaborator employed by a foreign entity or a non-U.S. vendor, and/or with financial support or resources from a foreign entity), whether or not funding is requested to support activities to be performed at a foreign site and/or by a foreign entity.

Returning Applicants

Past Tufts CTSI award recipients are welcome to re-apply to obtain funding for a new research project, but will not be considered for additional funding for a project previously awarded through the program. Lead PIs or Co-PIs who have received two Tufts CTSI pilot awards are not eligible to apply as key personnel for another award until five years from the end date of their last award. To be considered for new funding, returning applicants must comply with all prior award reporting requirements.

Application Process

Available Pre-award Resources and Services

Applicants are strongly encouraged, but not required, to work with the Tufts CTSI Navigators, the Biostatistics, Epidemiology, and Research Design (BERD) Center, the Stakeholder and Community Engagement Team, the Recruitment and Retention Support Unit, the Integrating Underrepresented Populations in Research Team  the Informatics Team, and other Tufts CTSI service providers to enhance proposal development by advancing study design, ensuring translational capacity, fostering collaboration, and identifying infrastructure support. Please request a consultation by filling out our online form.

How to Apply

The 2022 Pilot Studies Program has a two-step application process that includes a competitive LOI and, if invited, a final proposal. Both must be submitted via Tufts CTSI’s REDCap online submission portal. Incomplete and late submissions will not be accepted.

  • Competitive Letter of Intent: To be considered for a full proposal, applicants are required to provide a research synopsis, specify the project’s translational phase(s), and detail the composition of the research team. The LOI narrative should provide a well-communicated summary of the proposed study with sufficient detail, including a statement of the translational relevance and significance, a description of potential benefits, a list of specific aims, and an overview of research procedures. The LOI should total no more than three pages in length. Applicants must use Arial at a font size of 11 points and keep all margins at 0.5 inches. The LOI submission should also include biosketch(es) of Principal Investigator(s). LOI submissions will be accepted on a rolling basis through Wednesday, September 30, 2021. View LOI instructions, download templates, and apply here.
  • Proposal, by invitation: If invited, applicants will be invited to submit a full proposal. Detailed proposal instructions and program-specific form templates will be available in REDCap upon invitation before or on Monday, November 1, 2021. Full proposals must be submitted by no later than Monday, December 13, 2021.

Letter of Intent Review

The LOI review process is designed to ensure alignment with the program objectives, help identify the most promising and scientifically sound research projects to move forward, and to support further project development. All complete LOIs will be assessed and scored based on the following criteria: significance, innovation, approach, and investigators. Successful projects will be selected in consultation with the Tufts CTSI Biostatistics, Epidemiology, and Research Design (BERD) Center, Research Collaboration Team, Evaluation and Continuous Improvement, Stakeholder and Community Engagement, and Integrating Underrepresented Populations in Research Programs, as appropriate. Full proposals will be accepted by invitation only.

Proposal Review and Funding Decision

All complete proposals will be assessed and scored on the basis of the following criteria: significance, innovation, approach, investigators, environment, and future plans. Key funding considerations include the overall impact score, project feasibility, clear strategy and intentional focus on health equity, budget justification, available funds, and distribution across the translational spectrum. Please learn more about the application review criteria and funding decision here.

Questions?

Please review our frequently asked questions (FAQs).

Need further assistance? We are here to help. Please contact us at pilots@tuftsctsi.org with any questions or to schedule a virtual consultation.

Aviva Must, PhD, Director of the Pilot Studies Program

Daniel Jay, PhD, Associate Director of the Pilot Studies Program

Nadia Prokofieva, MA, Senior Project Manager