PMHDC Principal Investigators:

Transcription

1 OVERVIEW Precision Medicine (PM) is an approach to disease detection, prevention, and treatment based on people s individual differences. The Precision Medicine and Health Disparities Collaborative (PMHDC, NIH Grant #MD010722) was established in 2016 as a regional partnership to enable research using PM approaches to improve health in African Americans and Hispanics/Latinos in the Southeastern US. Led by Vanderbilt University Medical Center (VUMC), Meharry Medical College (MMC), and the University of Miami (UM), the PMHDC is guided by Advisory and Ethics Boards, comprised from community based organization members and minority-serving academic institution members who provide overall and project-specific guidance. PURPOSE OF RFA African Americans and Hispanics/Latinos continue to experience disproportionately higher chronic disease burdens compared to non-hispanic whites. The primary drivers of these racial/ethnic health disparities (HD) include a complex interplay of social, behavioral, environmental, and biological factors. Despite this knowledge, there is still a need to identify evidence-based interventions that can reduce and ultimately eliminate HD. By taking into account individual variation in preventing, detecting, and treating disease, PM holds considerable promise as an emerging, yet understudied, strategy for addressing HD. This Request for Applications invites pilot projects that leverage PM to 1) enhance understanding of the interplay among biological, behavioral, sociocultural and environmental factors involved in health conditions that disproportionately impact health outcomes in African American and Hispanic/Latino populations and 2) develop individually-tailored PM based detection, prevention and treatment strategies to reduce HD. The purpose of these HD pilot projects is to serve as a means to stimulate emerging PM research areas, explore new PM methodologies or approaches, conduct demonstration projects to test implementation of promising PM interventions in community settings, and generate preliminary data to support development of independently funded projects. Appendix A includes examples of some topics of interest. Applicants are not limited to those as research areas. However, please note that basic science projects are not eligible for funding through this pilot project program. Key Dates Application Due Date/Time: July 15, 2017 (6PM EST) Scientific Merit Review Completion Date: July 30, 2017 NIMHD Administrative Review: September 15, 2017 Project Start Date: October 1, 2017 (tentative) Available Funding: The PMHDC will award up to three pilot awards up to $50,000 direct costs each for a one-year period. The proposed project cannot duplicate aims of any currently or previously funded award. Eligibility: Any faculty member or full-time employee at a PMHDC member organization (Vanderbilt University, Meharry Medical College, the University of Miami, and the University of Mississippi Medical Center) having the skills and experience to conduct the proposed work may submit an application. Faculty or employees of the organizations in the PMHDC Advisory Board or Ethics Advisory Board are also eligible to submit applications. If you are uncertain about your institution s eligibility please contact us. PMHDC Principal Investigators: Consuelo H. Wilkins, MD MSCI, Executive Director, Meharry-Vanderbilt Alliance Nancy J. Cox, PhD, Director, Vanderbilt Genetics Institute Maria de Fatima Lima, PhD, Dean of Graduate Studies and Research, Meharry Medical College Roy E. Weiss, MD PhD, Chair of Medicine, The University of Miami Miller School of Medicine

2 APPLICATION INSTRUCTIONS Submission Format: The application should be submitted as a single pdf file. Applicants must use PHS 398 continuation page format. Margins must be no less than 0.5 inches and text must be in Arial 11 point font size or larger. The application must be ed to: Ms. Brendaly Rodríguez at brodriguez@med.miami.edu. Applications should include the following components: 1) Cover page (one page) a) Project Title b) Principal Investigator (Name and Title) c) Organization/Institution d) Address, Phone and e) Requested Amount f) Lay abstract: A short abstract, not to exceed 200 words, for release to the general public should this application be chosen for funding. 2) Project Summary: (one page): Please provide a scientific abstract of no more than 400 words that concisely summarizes the proposed work including aims, research design and methods. Include relevance of the project to HD and PM. 3) Bio-sketch: (Use NIH format, up to 5 pages each): Include bio for the principal investigator and up to one additional key investigator or project personnel (if needed). 4) Specific Aims (1 page): Concisely state the goals of the proposed research and summarize the expected outcome(s). In this section also briefly summarize plans for subsequent funding of the project based on project s results and the impact that the results of the proposed research may have on HD and PM research and/or clinical practice. 5) Project Description (up to 4 pages, no appendices allowed) a) Significance: Include purpose of the project, importance of the problem to be addressed, relevance to HD and PM, and description of the population and/or community to be served by the project b) Innovation: Explain how the application challenges and/or seeks to shift current HD/PM research or clinical practice including any novel concepts, approaches or methodologies or intervention(s) to be developed. Innovative approaches for community/stakeholder engagement should also be highlighted in this section. c) Approach: Describe the overall strategy, methodology, and analyses to be used. If appropriate, include feasibility, preliminary studies, potential problems and alternative strategies. If not already discussed, include role of relevant stakeholders and /or community engagement in the design and conduct of the study. d) Bibliography and References (not included in page limit) 6) Budget Narrative (1 page). Provide a brief explanation/justification of how you expect to allocate the dollar amounts in different areas, including (as appropriate) support for investigator salary. If awarded, a formal budget using PHS 398 budget pages, will be required. The PMHDC will work with your organizational representatives to develop this. (see appendix B for general budget guidelines) 2

3 APPLICATION REVIEW CONSIDERATIONS: It is expected that these pilot proposals applications will be equivalent in scope to R03 and/or R21 grants submitted to the NIH. The proposals will be reviewed using current NIH review criteria. These include overall impact, significance, investigator, innovation, and approach. Additional review criteria will include HD/PM focus, relevance of populations being served, and degree of community/stakeholder engagement. Applications meeting compliance with all guidelines will be reviewed by a panel to be established through the PMHDC Consortium Core. In addition, all applications that are recommended for potential funding will undergo an administrative review by staff at the National Institute of Minority Health and Health Disparities (NIMHD). Pre application assistance: Applicants who would like more information on resources available to help in the preparation of an application including guidance from the PMHDC Training and Mentoring core should contact us at least one month before the application deadline. Funding acknowledgement: All funded applicants must agree to acknowledge the granting agency in each publication, press release, or other document related to your project, using this language: Research reported in this publication was supported by the National Institute on Minority Health and Health Disparities (NIMHD) and the National Human Genome Research Institute (NHGRI) of the National Institutes of Health under Award Number U54MD The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. CONTACT INFORMATION: For any question, inquires, or additional information please contact: Brendaly Rodríguez, MA at brodriguez@med.miami.edu or Leadership: PMHDC Principal Investigators: Consuelo H. Wilkins, MD MSCI, Executive Director, Meharry-Vanderbilt Alliance Nancy J. Cox, PhD, Director, Vanderbilt Genetics Institute Maria de Fatima Lima, PhD, Dean of Graduate Studies and Research, Meharry Medical College Roy E. Weiss, MD PhD, Chair of Medicine, The University of Miami Miller School of Medicine PMHDC Core Leads: Consortium: Olveen Carrasquillo, MD MPH, The University of Miami Miller School of Medicine Implementation: Sunil Kripalani, MD, Vanderbilt University Medical Center Biospecimen & Clinical Data: Joshua C. Denny, MD MS, Vanderbilt University Medical Center Training & Mentoring: David W. Haas, MD, Vanderbilt University Medical Center Adminstrative: Sarah C. Stallings, PhD, Meharry-Vanderbilt Alliance 3

4 Appendix A. Examples of potentially relevant HD and PM research. Health Disparities Research: NIH defines health disparities as differences in the incidence, prevalence, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups. Health Disparities (HD) research includes basic, clinical and social sciences studies that focus on identifying, understanding, preventing, diagnosing, and treating health conditions such as diseases, disorders, and other conditions that are unique to, more serious in, or more prevalent in subpopulations in socioeconomically disadvantaged (i.e., racial/ethnic minorities, low education level, live in poverty) and medically underserved, rural, and urban communities. However, for the purposes of this funding opportunity, basic science research is not eligible for funding. See examples below of potentially relevant HD and PM research topics that were highlighted by NIMHD in the RFA that led to the establishment of the PMHDC. Applications are not limited to these areas. ( 1. Data integration: Research that focuses on the development of better tools and analytic methods for integrating different types of data obtained from individuals ("omics" data, clinical data, behavioral survey data, etc.) with structured information about key contextual factors (social stratification, racism and discrimination, community ecological context, cultural factors, environmental factors, health-related policies, etc.) that act at the community or population level to influence the health of individuals. Approaches that leverage public and private-sector investments in health information technology, public health reporting systems, clinical data research networks, and informatics tools to identify patients from diverse populations with specific clinical characteristics for cohort studies are strongly encouraged. Topics of interest include but are not limited to: Variations in biomarkers and their interactions with relevant contextual predictors in clinical research cohorts and/or patient registries involving multiple chronic diseases or co-morbid conditions; Feasibility of pooling and augmenting diverse datasets from multiple existing clinical research cohorts (observational studies, population studies, clinical trials) to enhance predictive power and enable examination of differences between sub-populations; Development and testing of risk prediction models that incorporate cultural practices and other contextual factors that support healthful behavior and resilience and resistance to disease. 2. Population differences in pharmaceutical therapy outcomes: Striking differences in health outcomes related to obesity, infant mortality, cancer, cardiovascular disease, hypertension, asthma, diabetes and HIV infection in disparity populations are well established. Significant differences also exist among various HD populations in responses to therapeutic drugs. The PMHDC supports research that examines population differences in pharmaceutical therapy outcomes and correlations with biological and contextual predictors (see examples above) to better understand variability in drug responses and identify effective patient-specific treatments that enhance therapeutic outcomes in patients from health disparity populations. Topics of interest include but are not limited to: Differential response to drug treatments; Relative efficacy and effective dosage; Differential side effects and toxicity, including genetic sequencing of known drug metabolizing enzymes to better understand variability associated with risks for toxicity; Differential rate and mechanisms of relapse; 4

5 Novel therapeutics or device strategies that optimize or modulate existing therapies to enhance clinical outcomes in health disparities populations. 3. Translating pharmacogenomic discoveries to health disparity populations: A major limitation of existing pharmacogenomic-based therapies is that most of the data informing clinical guidelines are derived from populations of European descent. The PMHDC encourages clinical and translational research to study genomic variations that impact the specificity and response of drugs in patients from diverse racial/ethnic populations and evaluate other factors that may contribute to variability of responses across different populations. Topics of interest include but are not limited to: Clinical validity and utility of predictive testing based on genomic information, particularly for disease screening, prevention and/or treatment for complex diseases and co-morbid conditions in one or more health disparity populations; Foundational studies in pharmacogenomics to incorporate whole and partial genome sequence and other deep resequencing efforts (e.g., selected regions of the genome) towards predicting drug actions and patient responses among various health disparity populations; Data-driven approaches utilizing patient-derived specimens to move beyond genome sequence (and sequence variation), integrating and modeling multidimensional datasets (e.g., transcriptome, proteome, epigenome, metabolome, etc.) to better predict drug response and adverse reactions. 4. Implementation research: Research on potential facilitators and barriers to implementation and adoption of PM approaches in health disparity populations. Topics of interest include but are not limited to: Acceptability of comprehensive genetic testing and phenotypic profiling in clinical settings, both for patients and healthy individuals; Potential individual-level factors that influence patient attitudes toward precision medicine approaches, such as age, gender, family history, severity of adverse health conditions, issues surrounding doctor/patient communication, concerns about privacy and confidentiality, etc.; Community-level and/or cultural or societal factors that affect implementation and adoption, including but not limited to risks associated with stigma; Acceptability among health service providers and systems that serve health disparity populations, including but not limited to issues surrounding access, cost, and reimbursement for clinical services; Development of culturally consistent and acceptable approaches to overcoming barriers and enhancing facilitators. 5

6 Appendix B: General Budget Guidelines A. Allowable Expenses: 1. Investigator(s) salary 2. Salary support for research staff 3. Consultants, including stakeholder/community partners on the project 4. Research supplies 5. Domestic travel when necessary to carry out and disseminate the proposed research 6. Publication costs, including reprints 7. Special fees (pathology, photography, etc.) B. Non Allowable Expenses: 1. Indirect Costs. 2. Administrative/secretarial/ grants management personnel 3. Tuition and stipends 4. Foreign travel 5. Non-research services to patients 6. Construction or building maintenance 7. Major alterations 8. Purchasing and binding of periodicals and books 9. Office and laboratory furniture 10. Office equipment and supplies 11. Rental of office or laboratory space 12. Dues and membership fees in scientific societies 6