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 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 – thereby improving the health and wellbeing 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. They should also have an integrated strategy for engaging relevant stakeholders to support collective action for health improvement throughout all key stages of project implementation.

Eligible applicants include members of Tufts CTSI academic, medical, industry, non-for-profit, and community 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, 2019 and ending April 30, 2020, pending National Institutes of Health (NIH) approval.

The application period for the 2019 Pilot Studies Program awards is now open. 

The Letter of Intent submission period is closed.

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, industry, not-for-profit, or community partner or collaborator institution. 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 that the application period for the 2019 Pilot Studies Program is now open. Letters of Intent (LOIs) were accepted through Monday, October 15, 2018.

Pre-Award Key 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

Application Steps

The Pilot Studies Program has a two-phase application process that includes a brief LOI and a final application. The LOI is used to assess applicant eligibility, and to begin collaborative project development, protocol development, and budget discussions. Please note that only applicants submitting an LOI will be eligible to submit a complete application.

Available Resources and Services

Applicants are strongly encouraged, but not required, to work with the Tufts CTSI Navigators, the Stakeholder and Community Engagement Team, the Biostatistics, Epidemiology, and Research Design (BERD) Center, and other Tufts CTSI services to catalyze proposal development by advancing study design, fostering collaboration, identifying infrastructure support, and improving grantsmanship. Tufts CTSI can provide methodological and technical support, recommend additional project team members, assist teams with project planning, 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 the Tufts CTSI prior to submitting an LOI, or during the proposal development phase, please request an in-person or virtual consultation here.

Information Sessions

Watch the video and view the slides (PDF) from the 9/27 and 10/2 Online Information Sessions.

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 strive to achieve these goals by providing education, consultation, services, and direct support.

Supported by the National Center for Advancing Translational Sciences (NCATS) – one of 27 Institutes and Centers at the National Institutes of Health (NIH) – Tufts CTSI and more than 50 institutions across the country with Clinical and Translational Science Awards (CTSAs) impact 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, including, diagnostics, therapeutics, medical procedures, behavioral interventions, and 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 the 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 the translational spectrum for Tufts CTSI, please click here.

Program Priorities

Tufts CTSI is committed to supporting investigators from Tufts CTSI collaborator or partner institutions in the development of novel research methods and approaches that address translational roadblocks and projects that can answer important scientific questions. Consistent with the NCATS mission and local priorities, the Pilot Studies Program funds translational and clinical research across the full T.5 to T4 spectrum rather than basic discovery research. In alignment with both NCATS research priorities and Tufts CTSI strengths, the program also prioritizes translational research projects in one or more areas of:

  • 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 partner or collaborator institutions, which span academic partners, affiliated hospitals, industry, and not-for-profit and community-based organizations. Proposals must designate a Principal Investigator (PI) with a primary appointment or position at a Tufts CTSI-affiliated 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

Industry and Not-for-Profit Partners and Collaborators

  • Blue Cross Blue Shield of Massachusetts
  • Massachusetts Biotechnology Council
  • 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

A list of eligible partners and collaborators can be found here.

Multi-Site Research Teams

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. 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.

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. Members of multi-site research teams must meet all Pilot Studies Program eligibility requirements. They may allocate funds across sites in accordance with project needs.

Allowable Costs

For all awards, funds may be used as direct costs for investigator and support staff, such as research assistants and technicians, salary and fringe benefits; clinical support; laboratory research supplies; or for assistance with biostatistics and biomedical informatics. 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. Please note that indirect costs, such as, but not limited to, general office supplies, clinical equipment, membership dues, professional fees, or items generally considered “facilities and administrative” expenses, are not provided.

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 Selection Criteria

Scientific Peer Review

All complete applications will be peer reviewed by at least two reviewers with relevant expertise. The reviewers will be primarily selected from the pool of Tufts CTSI Pilot Studies Program Scientific Training and Review Committee members which includes past pilot award recipients and other representatives from Tufts CTSI partner and collaborator institutions. The review process will follow NIH guidelines for peer review, based on criteria listed below.

Relevance – ability to meet NCATS and Tufts CTSI objectives by demonstrating a clear translational path and explicit relevance to improved health.

  1. Has a strong case been made in regard to advancing translational research (as opposed to basic discovery research)?
  2. Does the project address an important question or problem in a Pilot Studies Program priority research area: Comparative Effectiveness Research, Methods Development, and One Health?
  3. Will the project yield a broadly applicable, generalizable solution to a translational problem?
  4. Will the proposed work have a broad application across disciplines?

 Significance – quality and merit of the proposed research project.

  1. Does the project address an important problem or critical barrier to progress in translation?
  2. If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
  3. How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?
  4. If the development of new methods is proposed, do the methods enable an approach to research that is new, otherwise not possible, or less effective with current methods?
  5. Does the project meet federal requirements for scientific rigor and transparency? For guidance on these requirements, applicants are encouraged to view a seminar and related materials.

 Innovation – potential for impact through development of novel solutions and processes.

  1. Does the project challenge and seek to shift current research or clinical practice paradigms by using novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
  2. Does the project involve the development of novel methods or a new application of existing methods?
  3. Does the project take an interdisciplinary approach to answering a question or solving a problem?

 Investigators – qualifications of the research team to carry out proposed research.

  1. Do the investigators/collaborators for the project have the appropriate skills and training to complete the project?
  2. If a multi-site project is proposed, is it clear how the research is linked across sites?

 Environment – availability of resources to support proposed research.

  1. Will the scientific environment in which the work will be done contribute to the probability of success?
  2. Are institutional support, equipment, and other physical resources available to the investigators adequate for the proposed project?
  3. Will the project benefit from unique features of the scientific environment, participant populations, or collaborative arrangements?

 Approach – scientific rigor of the proposed clinical or methodological design plan to meet proposed objectives and goals.

  1. Is the project innovative, with a high likelihood of being successfully developed during the award’s one-year time frame?
  2. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
  3. Does the proposal outline a clear plan for involving community members and other stakeholders in the conceptualization, implementation, interpretation, or dissemination of study findings? If not, is a compelling rationale for their exclusion provided?
  4. Are potential problems, alternative strategies, benchmarks for success, and a project timeline presented?
  5. If the project is in the early stages of development, will the strategy establish feasibility while minimizing risk?
  6. Is a statistical analysis plan clearly articulated (including a power analysis) and adequately funded in the proposed budget?
  7. Is there a clear plan for full compliance with all federal, state, and institutional policies, rules, and guidelines regarding biomedical ethics?

 Future Plans – clear articulation of next steps.

  1. Can the preliminary data that support the proposed project, including data from the literature, be used to develop hypotheses for future testing?
  2. If the development of new research methods is proposed, are the methodological applications and plans for publication and dissemination clearly outlined?
  3. Does the proposal outline specific steps for publication of results in the peer-reviewed literature if the pilot project is successful and a plan for reporting negative results if it is not successful?
  4. Are plans for subsequent funding clearly defined? Is the future project feasible as a basis for future R01- or P01-type applications? Please note that this is not a requirement of methods development proposals.

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 decisions will be made independently by the Tufts CTSI Senior Leadership Team based on the Scientific Training and Review Committee’s funding recommendations, overall impact score, available funds, the funding level required for study implementation, and distribution by translational spectrum. 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, all applications will 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 and the Scientific Training and Review Committee.

Questions?

Please refer to our Frequently Asked Questions page.

Please also watch the video and view the slides (PDF) from our 2019 Online Information Sessions.

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