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 including investigators from the basic, clinical, and/or applied sciences. 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 $30,000 per award. To stimulate collaboration, research teams including investigators from two Tufts CTSI-affiliated institutions may request up to $45,000 per award and three institutions up to a maximum award amount of $60,000. Selected projects will be funded for one year, beginning May 1, 2020 and ending April 30, 2021, 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

Tufts CTSI is pleased to announce the launch of the 2020 Pilot Studies Program. This year’s completion is a one-step application and review process without the previously-required letter of intent. Complete applications and any accompanying materials must be submitted online by no later than Friday, September 27, 2019. Click here to access the Pilot Studies Program application, instructions, and forms.

Pre-Award Key Dates

  • Application submission period begins: Monday, July 8, 2019
  • Information webinars: Wednesday, July 17 and Thursday, August 8, 2019
  • Application submission period ends: Friday, September 27, 2019
  • Award announcements: late December 2019

How to Apply

The Pilot Studies Program application consists of fields to be filled in online and three program-specific forms, which must be completed and uploaded as part of the application in REDCap. Click here to access the Pilot Studies Program application, instructions, and forms.

Application Outline

  • Project abstract (maximum 250 words)
  • Project summary (maximum one page)
  • Background and significance (maximum two pages)
  • Specific aims (maximum one page)
  • Research procedures (maximum three pages)
  • Stakeholder engagement plan (maximum one page)
  • Alignment with selected translational research phase(s) (maximum half a page)
  • Leadership plan for multi-site or single site Multiple PI projects, if applicable (maximum half a page)
  • Description of next steps, including a plan and timeline for dissemination of research findings and for seeking extramural funding (maximum one page)
  • Bibliography (maximum one page)

Forms

  • Applicant certification and authorization (for lead site only)
  • Budget and budget justification (one per eligible site)
  • NIH-format biosketch(es) for senior/key personnel (maximum five pages per biosketch)
  • Letter(s) of support/commitment (optional)
  • Research protocol(s) (optional)
  • Recruitment and retention plan(s) (optional)

Information Webinars and Virtual Drop-in Sessions

The Pilot Studies Program team will host two online information webinars on Wednesday, July 17, 2019 at 8:30AM and Thursday, August 8 at 4:00PM. If interested, please register for either webinar by sending an email to pilots@tuftsctsi.org, or you can access the August 8 session here. The team will also be available to answer questions and offer guidance virtually on Tuesdays and Fridays from 4:00 to 6:00PM July 30 through September 27. To attend a virtual drop-in session, please click here to log into WebEx and enter meeting number 852 300 353 and password: CTSI. To join by phone, please call 617-627-6767 and enter access code: 852 300 353. No prior registration is required.

Available 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 Informatics Team and other Tufts CTSI service providers to enhance proposal development by advancing study design, fostering collaboration, and identifying infrastructure support. Tufts CTSI can provide methodological and technical support, recommend additional project team members, assist teams with project planning and development of recruitment plans, and help identify and involve relevant stakeholders and community representatives. In addition, Tufts CTSI can assist applicants with meeting all eligibility, multi-site team, and funding requirements, and respond to Tufts CTSI funding priority areas. If you would like to speak to a member of Tufts CTSI prior to or during the proposal development phase, please request an in-person or virtual consultation here or email the Pilot Studies Program team at pilots@tuftsctsi.org.

The Tufts CTSI Pilot Studies Program

About Tufts CTSI

Tufts CTSI’s mission is to stimulate innovative broadly-engaged team science across the translational research spectrum to improve clinical care and health. We link scientists and scholars from a wide range of disciplines with clinical investigators, policy makers, and industry and community leaders to collaborate in conducting innovative clinical and translational research. We cultivate this collaboration and innovation by offering education, consultation, research expertise, and financial support to investigators.

Supported by the National Center for Advancing Translational Sciences (NCATS), Tufts CTSI is one of  more than 50 Clinical and Translational Science Awards (CTSAs) institutions across the country that impacts health by promoting clinical and translational science. Translation, as defined by NCATS, is 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, behavioral interventions, and, ultimately, health policy. 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 incorporates clinical insights and relevant constraints into pre-clinical studies with the explicit, well-defined, and foreseeable purpose of delivering effective and impactful health care interventions. To learn more about translational science and translational spectrum for Tufts CTSI, please click here.

About the Program

The Pilot Studies Program provides one-year awards to individual investigators and research teams at Tufts CTSI-affiliated partner and collaborator institutions. Launched in 2009, the program supports innovative, interdisciplinary, high-impact, translational science projects that have the potential to answer important scientific questions and to develop novel research methods and approaches to address translational roadblocks. Consistent with the NCATS mission and local priorities, the program funds translational and clinical research across the full T.5 to T4 spectrum rather than basic discovery research. In alignment with NCATS research priorities and Tufts CTSI’s strengths, the program also prioritizes translational research projects in:

  • Comparative Effectiveness Research (CER): compares the benefits and harms of alternative interventions, including improving health care delivery to prevent, diagnose, monitor, or treat a clinical condition.
  • Methods Development: supports the development of new, generalizable, and broadly-applicable procedures, techniques, and tools for approaching and solving translational research questions, problems, or barriers.
  • One Health: promotes integrative solutions for medical issues by incorporating expertise from diverse fields that study the health of humans, animals, and the environment.

Eligibility

Principal Investigators and Research Team Members

Eligible applicants include members of Tufts CTSI-affiliated institutions, which span academic partners, affiliated hospitals, for-profit and not-for-profit collaborators, and community-based organizations. Proposals must designate a Principal Investigator (PI) with a primary appointment or position at a Tufts CTSI partner or collaborator institution. Research teams may include other key personnel members who contribute to the scientific development and execution of a project in a substantive, measurable way. Please refer to the list of Tufts CTSI partners and collaborators listed below.

Eligible Sites

Academic Partners and Collaborators

  • Brandeis University
  • Massachusetts General Hospital Institute of Health Professions
  • Massachusetts Institute of Technology
  • Northeastern University
  • RAND Corporation
  • The Jackson Laboratory
  • Tufts University (PLEASE NOTE: 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).

Clinical Partners and Collaborators

  • Baystate Medical Center
  • Lahey Hospital and Medical Center
  • Maine Medical Center
  • New England Baptist Hospital
  • Newton-Wellesley Hospital
  • St. Elizabeth’s Medical Center
  • Tufts Medical Center

For-profit and Not-for-Profit Partners and Collaborators

  • Blue Cross Blue Shield of Massachusetts
  • Massachusetts Biotechnology Council
  • Novartis
  • Pfizer, Inc.
  • Tufts Health Plan

PLEASE NOTE: For-profit institutions are eligible as participant sites, but they cannot receive funding.

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

Eligibility Criteria

  1. Principal Investigator with a position or faculty appointment at a Tufts CTSI partner or collaborator institution (research teams may include collaborators who are and who are not affiliated with Tufts CTSI)
  2. No current funding for the proposed project or only modest intramural or extramural funding that will be enhanced by the pilot activities

Returning Applicants

Past Tufts CTSI pilot 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. Failure to report study outcomes may preclude the PI, Co-PI, or Co-I from being eligible for new Tufts CTSI funding.

Budget Guidance and Requirements

Funding Amounts

Awards will be made to eligible individuals or research teams for up to $30,000 per award. Multi-site projects including two eligible sites may request a total budget of up to $45,000 and including three eligible sites a total budget of up to $60,000. Funds for multi-site projects may be allocated across sites in accordance with project needs.

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 institution who will serve as a lead contact at that site. Research teams may also include collaborators who are not affiliated with Tufts CTSI, but their organization will not be considered as a funded site for a multi-site proposal.

Allowable Costs

For all awards, applicants may only request direct costs that are necessary and reasonable to complete the work described in their applications. Such direct costs may include key personnel and support staff salaries and fringe benefits; consultant services; clinical support; stipends or compensation for stakeholders involved in the project; participant incentives; and laboratory research supplies. Salary support for existing personnel must be justified and include a description of past support and plans for future support after the Tufts CTSI-supported pilot project is completed. Indirect costs are not allowed and will not be covered.

Cost Sharing

Cost sharing is the portion of pilot project costs that are not paid for by the pilot project budget.
Cost sharing for investigator salaries is discouraged and will be allowed only with written approval of both the appropriate department chair and senior administrator.

Subcontracts

Subcontracts, if necessary, should be budgeted separately in the research proposal.

Application Review Process and Considerations

Application Review Criteria

All complete applications, including stakeholder engagement plans, will be reviewed and rated using the 9-point rating scale (1=exceptional; 9 =poor). The review process will follow the NIH scoring guidelines based on the criteria listed below. To learn more about the application review process and criteria, please click here.

Scientific Training and Review Committee Review

  1. Relevance ability to meet NCATS’ and Tufts CTSI’s objectives by demonstrating a clear translational path and explicit relevance to improved health.
  2. Significance– quality and merit of the proposed research project.
  3. Innovation– potential for impact through development of novel solutions and processes.
  4. Investigators– qualifications of investigators to carry out the proposed research project.
  5. Environment– availability of resources to support the proposed research project.
  6. Approach– scientific rigor of the clinical or methodological design plan to meet the proposed objectives and goals.
  7. Future Plans– clear articulation of next steps for future research, dissemination of project results, and seeking future funding.

Stakeholder Expert Panel/Stakeholder and Community Engagement Task Force Review

  1. Stakeholders ability to identify key stakeholder groups and determine the role they play or may play in the proposed research project.
  2. Approach rigor of the stakeholder engagement plan to meet the proposed objectives and goals.
  3. Relevance ability to demonstrate explicit relevance of the project and its outcomes to the identified stakeholder groups and the public.

Relevance to Priority Research Areas

Top-scoring applications will be evaluated by Tufts CTSI Program Leaders for relevance to the priority research areas identified by Tufts CTSI (Comparative Effectiveness Research, Methods Development, and One Health). Applicants will receive a 0.5 point improvement in their overall impact score, up to a maximum of 1.0 point, for each priority area successfully addressed in the proposed project.

Funding Decision

Final funding decision will be made independently by the Tufts CTSI Senior Leadership Team based on recommendations of the Scientific Training and Review Committee and Stakeholder Expert Panel/Stakeholder and Community Engagement Task Force, and on the overall impact score, budget justification, available funds, and distribution across the translational spectrum. Preference will be given to new rather than established projects or extensions of ongoing research projects. All applicants will be informed of the outcome of their submission via email. Reviewers’ comments will be provided to all primary applicants, regardless of whether or not they are awarded funding.

Research Collaboration Team Review

In addition to review by the Pilot Studies Program Scientific Training and Review Committee and Tufts CTSI Program Leaders, applications may be reviewed by the Tufts CTSI Research Collaboration Team to identify projects for further development and submission to other funding announcements, and/or to identify potential collaborators. Applicants may be contacted by Tufts CTSI Navigators or other members of the Research Collaboration Team for future research opportunities.

Confidentiality and Non-Disclosure

All proposals will be deemed proprietary and confidential and will be protected against any unauthorized use and any unauthorized or uncontrolled disclosure beyond Tufts CTSI, the Scientific Training and Review Committee, and Stakeholder Expert Panel.

Questions?

Please refer to our Frequently Asked Questions page.

Need further assistance? We are here to help. Please contact us at pilots@tuftsctsi.org.

 

Aviva Must, PhD, Director of the Pilot Studies Program

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

Nadia Prokofieva, MA, Project Manager