CTSI Translational Science Pilot Funding Program

UCLA’s CTSI is the home of the National Institutes of Health Clinical and Translational Science Award (CTSA). One of the National Center for Advancing Translational Sciences (NCATS) goals is “More Treatments for All People More Quickly.” Achieving this goal is made possible through translational science. As such, this grant mechanism is focused both on translational science AND translational research. The NCATS definitions of translation, translational research, and translational science are below.

• Translation: The process of turning observations in the laboratory, clinic, and community into diagnostics or interventions that improve the health of individuals and communities – from diagnostics, preventions, and treatments to medical procedures and behavioral changes.
• Translational Research: The endeavor to traverse a particular step of the translational process for a specific target or disease. Translational research studies often focus on one disease, working along the translational process to bring discovery from bench to bedside.
• Translational Science: The field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. Translational science studies do not focus on one particular disease, but instead develop generalizable methods to overcome barriers to translational research, which can be applied to translational research across diseases, conditions, and treatments.

At least one aim of the project must be focused on a translational science innovation to address a barrier to translational research.  Additional aims may address a translational research-focused use case to test the translational science hypothesis. The project and aim(s) should be feasible within the grant budget and timeline.

Examples of scientific and operational innovations aimed at addressing barriers include, but are not limited to the following:

• Community engagement methods and technologies that increase the efficiency and effectiveness of intervention development and deployment, and measurement of their effects on improving health outcomes. Community engagement should be defined broadly to include local and distributed, physical and virtual communities.
• Education and training of translational research workforce using innovative features such as shared online resources, competency-based training, training in multi-disciplinary collaborative science, regulatory science, entrepreneurship and experiential learning experiences.
• Network capacity building to identify and fast-track particularly promising translational research projects, thereby reducing the time required for intervention development or validation of feasibility.
• Integration and translation of basic science and applied science for biomedical and behavioral research.
• Application of technology and methodology that are shown to be successful in other domains to address challenges in clinical and translational science.
• Transformative technologies (such as digital health, telehealth, data science, artificial intelligence, machine learning) to increase efficiency during implementation of clinical research studies or clinical trials (e.g., study site selection and activation, recruitment and retention, patient reported outcomes, biomarker identification and validation, data collection and analysis, risk communication, clinical monitoring, data and safety monitoring, interoperability of electronic health record systems and clinical research data management systems).
• Rapid response to urgent public health needs (e.g., opioid epidemic, Covid-19 pandemic, health disparity).
• Processes to establish or integrate multi-site cohorts of population of interest (e.g., pregnant women, rural population, underserved population).
• Strategies to engage understudied/underreported populations in clinical research and clinical trial.
• Best practices to address anticipated obstacles encountered during the conduct of clinical research and clinical trial (study site start-up, participant enrollment, consenting process, customized contract and agreement, implementation of single-IRB policy, regulatory approval, distribution of investigational products, transparency and building trust).
• Assessment of and approaches to improve clinical research and clinical trial efficiency (e.g., local and central IRB review duration, clinical trial designs, virtual clinical trials, hybrid and decentralized clinical trials).
• Customized training modalities targeting the needs of academic and non-academic clinical researchers (e.g., investigators, study coordinators, research pharmacists, patient investigators, community health workers, doulas, allied health professionals, physician assistants, nurse practitioners, midwives).
• Expansion of clinical research and clinical trial capacity beyond the academic or research institutions (e.g., dialysis centers, community hospitals, physician’s clinics, urgent care centers, nursing homes).
• Innovative and collaborative approaches to integrate local and regional clinical research networks and/or clinical data warehouses.
• Creative approaches to ensure surge capacity of clinical research professionals to rapidly respond to urgent public health needs.
• Leverage of Veterans Health Administration for system-wide implementation of new and disruptive approaches to address the health burdens of veterans and improve veteran’s health.
• Clinical, genetic or machine-learning approaches that speed the identification or accurate diagnosis of rare disease patients to shorten the diagnostic odyssey encountered by rare disease patients.
• Approaches that more rapidly identify the molecular underpinnings of rare genetic diseases and potential targets for therapeutics development, such as computationally assisted modeling.
• Development and use of master protocols, such as basket, umbrella or platform trials, that include many-diseases-at-a-time approaches for rare disease therapeutics development.
• Clinical trial readiness strategies, such as adapting and validating clinical outcome assessment tools, e.g., patient-, observer- or clinician-reported outcomes or assessment tools or scales, for rare disease-specific indications.
• Clinical studies of genome editors in the treatment of multiple rare genetic diseases.
• Strategies leveraging real world evidence (RWE)/real world data (RWD) collection to identify and test new uses of off-patent drugs that are marketed in the U.S. for a different indication (Please see Envisioning an actionable research agenda to facilitate repurposing of off-patent drugs).
• Innovative applications and integration of data science, informatics tools and/or artificial intelligence/machine learning to make data more meaningful, open and accessible for the scientific community (predictive modeling, algorithms, simulation technologies, creation and dissemination of knowledge networks).
• Good Algorithm Practices (GAPs) which includes model validation, data integrity, and generalizability (Please see Machine Intelligence in Healthcare).

Projects should be in alignment with the translational science principles (https://ncats.nih.gov/about/about- translational-science/principles) and occur across the full translational spectrum (https://ncats.nih.gov/about/about-translational-science/spectrum).

Special consideration will be given to projects that focus on UCLA cross-cutting theme areas, which include:

• Broadening the inclusion of participants in translational science research.
• Applying AI and data science strategies to accelerate translation.

The principal investigator (PI) must hold a faculty appointment at one of the CTSI sites (UCLA, Cedars-Sinai, Lundquist/Harbor, Charles Drew). A community partner may co-lead a project. Proposals from multi-disciplinary, cross-site teams will be the most competitive.

• Successful applications must align with the CTSI’s overarching mission (i.e., to produce and implement innovations that impact the greatest health needs of Los Angeles and the nation).
• Projects must be completed within one year. Cost extensions are only allowed under extraordinary circumstances. 
• The lead PI must submit a brief interim progress report at the half-way point (June 1, 2025) of the award that describes the progress towards project milestones. A final report must be submitted within 30 days of the project end date. Annual updates on project progress or continuation, publications, grants submitted, or grants awarded from this pilot work will be required as a condition of award.

1. Cover Page (1 page)
   1. Title of Proposal
   2. Name of principal investigator(s), co-investigators, and collaborators (include degree, departments, and college)
   3. Lay abstract (300-word max) – provide a succinct overview of the proposal, including how the proposal will address the translational roadblock. Assume that reviewers do not have technical knowledge in a specific field. Avoid or explain technical jargon, field-specific terminology, and acronyms. Abstracts should be written for a broad academic audience.
2. Body of Application (limit three pages)
   1. Specific Aims and Translational Science Relevance: List the specific aims and the rationale for each. Additionally, please 1) explicitly state the translational research barrier to be addressed, 2) include a statement of translational relevance and significance, and 3) provide a description of potential benefits of the proposed research outcome. Applicants should also describe how additional aims will support the translational science aim for a particular use case(s) and provide a description of research procedures used for the particular use case(s). In doing so, the relevant NCATS Translational Science scientific principles should be addressed. For more information, please visit https://ncats.nih.gov/training- education/translational-science-principles.
   2. Significance/Innovation: Describe how addressing the study aims will promote the translation of scientific knowledge into health impact. Describe how the aims, methods, etc. are innovative. In addition, researchers should address (a) clinical; (b) community; (c) economic, and (d) policy- related impacts that their project or its deliverables may have.
   3. Approach/Scientific Rigor and Reproducibility: Describe the activities that will be undertaken to address the study aims. Include a description of how scientific rigor and reproducibility will be ensured.
   4. Community Engagement: Specify plans for community connections, and define/describe your “community” or communities (e.g., patients, health care providers, community organizations, industry, government, educators, researchers, other groups within and beyond the university).
   5. Investigators and Environment: Describe the qualifications of the investigative team, the role each team member will perform, and resources in the environment that will support the conduct of the study. Indicate if this is a new team or new member(s) of the team. Describe the multidisciplinary and, if included, the cross-campus collaborations within the team as well as whether the team includes both junior and senior colleagues.
   6. Timeline, Anticipated Outcomes, and Future Plans: Describe the project timeline over the twelve- month period of requested funding. Plans for specific deliverables and outcomes should be specified, including dissemination of results. 
3. Literature Cited (no page limit)
4. NIH Biosketch for the PI and each co-investigator and/or collaborator. Format for biosketch available at https://ctsi.ucla.edu/nih-requirements/biosketches. Please save and submit sections in a separate PDF. using the following naming convention: Last name of the PI-TSPFP-SubmissionDate (e.g., Smith-TSPFP-12202024)
5. Budget and Budget Justification. Projects may request up to $75,000 direct costs for a project period of up to 12 months. Provide an itemized budget and budget justification including salaries, fringe, and other expenses. Funds may not be used to support:
   1. Faculty salaries 
   2. Student- or postdoctoral fellow-led research (Note: portions of stipends are permitted for postdocs and graduate students working directly on a faculty team’s pilot project)
   3. Tuition

   4. Funding for activities typically supported by departments and colleges (e.g., travel to other conferences, basic software purchase)

      Provide the name, email address, and phone number of your department's budget coordinator/financial analyst.

      Please save and submit budget and budget justification in a separate PDF. using the following naming convention: Last name of the PI-Budget-TSPFP-SubmissionDate (e.g., Smith-Budget-TSPFP-12202024)

Proposals should be single-spaced, in Arial 11 font, left-aligned with half-inch margins. Appendices should not be included. Your proposal must be complete when submitted and include all items noted above.

Full applications will be reviewed externally. Reviewers will consider each of the five review criteria (below) to assess merit.

• Significance: Does the project address an important problem or critical barrier to improving health and/or healthcare? Is the project’s translational potential clear and compelling? Does the project involve any special emphasis topics as outlined in Section I?
• Innovation: Does the project challenge or shift current research or practice paradigms, advance novel concepts, approaches/methods, instrumentation, interventions, or apply current methods in novel ways?
• Approach/Scientific Rigor and Reproducibility: Are the procedures and analysis plans justified and appropriate to accomplish the specific aims? Will the project provide the foundation for a competitive proposal for external funding and dissemination? How does the proposed project address the concepts of rigor and reproducibility per the NIH definition, https://www.nih.gov/research-training/rigor- reproducibility?
• Investigators: Do the PI and collaborators have the expertise needed to conduct the project? Do the investigators capitalize on differing disciplinary perspectives?
• Collaboration: How does the proposed project benefit from the collaboration of investigators? Is there a new member of the investigative team? Are the disciplines represented complementary, and does the research plan appear to build on the expertise of the entire team? Does the team leverage expertise from multiple disciplines, investigators at different career points, and across the University? Is the community connection for the project clear and well described?

Q: How is translational science differentiated from translational research?
A: Translational science is the development of generalizable methods to overcome barriers to translational research, which can be applied to translational research across diseases, conditions, treatments, health care delivery settings, and populations. 

Whereas, translational research traverses a particular step from basic science to the discovery toward improved diagnosis and treatment of a disease, i.e. from bench to bedside to populations. This research often focuses on one disease and one step of the process.

Q: Is there overhead assessed? If so, what would be the rate?
A: The $75,000 is for direct costs, no indirect costs need to be budgeted. 

Q: Is an EPAS required? If so, who would be the sponsor?
A: No EPAS is needed.

Q: Is this opportunity open to departments outside the School of Medicine?
A: Yes, there is currently no restriction on faculty's home department.