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Pilot Translational and Clinical Studies

Learn more about Pilot Translational and Clinical Studies.

  • What's It All About

    GHUCCTS is pleased to announce the availability of support for pilot and collaborative studies.

    Our Mission

    The mission of GHUCCTS and the national Clinical Translational Science Award (CTSA) programs includes promotion multidisplinary and inter-institutional teams and research that will translate basic findings into clinical applications and clinical research findings into community use in order to improve human health. Our Pilot Translational and Clinical Studies program (PTCS) has been a critical and effective stimulus for collaboration that has stimulated the development and implementation of new clinical and translational research (CTR) projects.

    The PTCS program is designed to bring about further advances that will contribute to improving the process of research throughout our CTSA hub and the national CTSA consortium. These contributions will draw upon a range of GHUCCTS capacities from community-based recruitment of underserved populations to the use of high performance computing in the development of therapeutic agents.

  • Who is Responsible

    Headshot of Dr. Thomas MellmanDirector of PTCS Programs : Thomas A. Mellman, MD

    Professor of Psychiatry
    Director of the Center for Clinical and Translational Research and Stress/Sleep Studies Program at Howard University College of Medicine.

    Dr. Mellman is Professor of Psychiatry and Director of the Center for Clinical and Translational Research and Stress/Sleep Studies Program at Howard University College of Medicine. He is the principal investigator representing Howard for the Georgetown Howard Universities Center for Clinical and Translational Science supported by a Clinical Translational Science Award from NIH. 

    He received training at the NIMH Division of Intramural Research Programs and has previously held faculty appointments and achieved the rank of Professor at the University of Miami and Dartmouth. Dr. Mellman has had continuous funding as PI on federal research grants since 1991 including a VA Merit award, and R01, R21, R34 and K24 awards from NIMH, NHLBI, NIMHD, and the DOD. His primary research interests have been the role of sleep in posttraumatic stress disorder (PTSD) and the role of sleep in the effects of stress on physical and emotional health. He has a consistent track record of mentoring junior investigators and interdisciplinary collaboration. He recently finished service as a member of the NIH study section for Mechanisms of Emotion Stress and Health, was previously a member of NIMH IRGs for Violence and Traumatic Stress and Interventions, and has served on several review committees for the NIH Roadmap and Department of Defense research programs. Dr. Mellman was a member of the original ISTSS committee for developing treatment guidelines for PTSD, APA committee for text revision of the DSM-IV, and the Institute of Medicine Committee for review of the evidence regarding the treatment of PTSD. He received the International Society for Traumatic Stress Studies distinguished mentorship award for 2016.

    Yejide Obisesan, Program Coordinator, HU CTSA Navigator

    Howard University
    Clinical Research Unit4-West
    Howard University Hospital
    2041 Georgia Ave., NWWashington, DC 20059
    Email: yejide.obisesan@howard.edu

  • Pilot Awards

    The PTCS program has funded over 20 pilot projects since 2015. 

    2019 - 2020

    Geospatial analysis of birth outcomes in Washington, DC and associations with environmental and community based factors
    Investigator: Kristin Atkins
    Institution: HU

    Identifying Factors that Predict Opioid Overuse in Hand and Upper Extremity Surgery Patients
    Investigator: Aviram Giladi
    Institution: MHRI

    How environmental factors alter the protective properties of the carbohydrate coat on cells
    Investigator: Preethi Chandran
    Institution: HU

    Novel Tools for Individualized Prediction of Changes in Glycemic Control Among Patients with Prediabetes
    Investigator: Jim Huang
    Institution: MHRI

    Community-based air quality monitoring and near source screening: Exploring the association between air quality and chronic school absenteeism in children with asthma
    Investigator: Laura Anderko
    Institution: GU

    A Machine Learning Model to Predict the Impact of Missense Variation on Inhibitor Binding to Janus Kinase 2
    Investigator: Matthew McCoy
    Institution: GU

    News Story | Download PDF


    2018 - 2019

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    2017 - 2018

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    2016 - 2017

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    2015 - 2016

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  • How To Apply

    The 2019 application cycle is closed. Our next application cycle will open in early 2020.


    The missions of Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) and the national Clinical and Translational Science Award (CTSA) programs highlight promotion of interdisciplinary research that translates basic research findings into clinical applications and clinical research into community practice, and improving the process of research. It is also our goal to implement research that will benefit underserved populations, including minorities, people with disabilities, and older adults. Additional priorities recently indicated by the agency that administers CTSAs, the National Center for Advancing Translational Science (NCATS), further emphasize interaction and collaboration of the 62 CTSA hubs spread throughout the United States.  

    Download 2019 RFA (PDF)


    2019 Pilot Translational and Clinical Studies (PTCS) Funding Priorities

    We are proposing a new core capacity in our recently submitted competitive renewal application to leverage emerging information technology to investigate environmental determinants of health. The proposed core includes collaborations with the Health Data Sciences and Urban Dynamics Institutes of Oakridge National Laboratories and the DC Department of Health. Information on contacting individuals at these institutes and their capacities can be obtained through Shannon Gopaul (Shannon.Gopaul@Howard.edu; 202-865-7260). We will be prioritizing applications that focus on this topic (environmental determinants of health). Potential to be advanced through the proposed core will be considered favorably though collaboration with our proposed partners is not required for applications at this time. Further questions can be addressed to Ms. Gopaul. Other priority topics overlap past announcements and reflect the evolving missions and priorities of GHUCCTS and NCATS.

    Summary of priority topics:

    • Investigations of environmental determinants of health, particularly those involving clinical and or public health data bases and geospatial mapping, and have potential to point toward solutions through surveillance or policy. 
    • Innovative community engagement methods and technologies including research aimed at engaging minority, vulnerable, or other understudied populations;
    • Research that brings together a new type of team;
    • Research that expands a translational research focus across the lifespan including to pediatric and/or geriatric populations;
    • Innovative approaches to the implementation of precision medicine;
    • Engaging individuals with Opioid Use Disorders in research and clinical care while developing effective models of care delivered within medical settings of interest;
    • Research to address health disparities and the significant burden of conditions that disproportionately affect rural, minority, and other underserved populations.

    Eligibility


    Applicants must have a full-time faculty appointment at one of the GHUCCTS institutions (Howard, Georgetown, DCVA Medstar, ORNL). Each application should identify a Contact PI that will be responsible for coordinating and submitting the application. Research teams can include collaborators who are not GHUCCTS affiliated.

    Funding Opportunity Description

    Award Amount: up to $40,000 (includes Institutional cost share)

    Duration: Funds must be spent by March 31st, 2020.

    50% cost-share with the applicant institution is required
    (In most cases this has previously been negotiated with the participating institutions.)


    Requirements for Applications


    Abstract:
     (250-word limit) To enable community representative review, we are requiring that abstracts be written to be understood by a lay audience and to not include or clearly define technical terms, and for the abstracts to address relevance to public/community health. Failure to provide such an abstract could lead to return of the application without it being reviewed.

    Narrative: A limit of four (4) pages (single spaced, 11-point font, minimum 0.5-inch margins) for description of Aims, Background and Clinical and Translational Impact, Supporting Preliminary Studies, Design and Methods. If the study involves human subjects the description of human subject considerations is not subject to this limit. References do not count towards 4-page limit. Include the contact PI’s name at the top of each page and consecutively number all pages in the applications at the bottom of each page

    Biosketches: Current NIH biographic sketch for each investigator and/or mentor.

    Budget Guidelines

    Budget: Funding will be provided for items essential to the conduct of the project.  The budget should identify budget details and total by using NIH budget page (PHS 398 Form Page 4). A separate budget is needed for each participating institution and subcontract.

    Budget Justification: Budget justifications should include all the roles and responsibilities of all personnel (paid and unpaid) and details on the purpose of all non-personnel cost requested. Please utilize the template located in the application.

    • Allowable Costs: Laboratory supplies, small equipment (if deemed essential to the conduct of the project), participant costs, consultants, research support personnel (salary/wages & fringe benefits), use of institutional/core and GHUCCTS services, travel necessary to perform research.
    • Unallowable Costs: PI salary support or faculty collaborators, office supplies, meals or travel for conferences, professional education or training, indirect costs,  
    • Budgets should not include indirect/F&A costs.

    Departmental and GHUCCTS Executive Approval: Before submitting a PTCS grant application, the PI and any Co-PI that will be requiring institutional cost share is required to obtain approval for submission from his/her departmental chair or division chief and the GHUCCTS executive at their institution, with assurance that appropriate time and resources will be made available to successful applicants. A form is provided in the application packet. GHUCCTS executive contacts are as follows:

    Howard Executive: Dr. Thomas Mellman (tmellman@howard.edu)

    Georgetown Executive: Dr. Joseph Verbalis (verbalis@georgetown.edu)

    DCVA Executive:  Dr. Marc Blackman (Marc.Blackman@va.gov)

    MedStar Executive: Dr. Neil Weissman (Neil.J.Weissman@Medstar.net)

    IRB/IACUC & Human Subjects

    Consistent with NIH policies, IRB or IACUC approval or exemption, as well as conflict of interest review will be required prior to transmission of funds and project implementation.

    Although Institutional Review Board and/or Institutional Animal Care & Use Committee approval is not required prior to application submission, we strongly encourage preparation of regulatory documents as soon as possible.  If human subjects are to be involved in the proposed project, provide a description of their involvement, specific risks to subjects who participate, and protection against those risks. Describe any sources of materials that will be obtained from human subjects as part of their participation. Provide assurance that the project will be reviewed and approved by the IRB.

    Applications will not be considered complete without all components.


    How to Apply


    Applicants will submit an online application. The 2019 application cycle is closed. Our next application cycle will open in early 2020. Please contact yejide.obisesan@howard.edu or ghuccts@georgetown.edu for more information. 


    Review Criteria and Process


    Applications will be peer reviewed and evaluated on the following criteria:

    • Relevance to the above priority themes/categories
    • Use of an interdisciplinary approach. (Consider going outside of your institution if required expertise is more readily available at other GHUCCTS institutions (Georgetown University, Howard University, MedStar, DC Veterans Administration Medical Center, and Oak Ridge National Laboratory) or other CTSA hubs. 
    • Promising direction for future extramural funding Clearly describes how proposed aims will provide opportunities for future externally funded applications, including but not limited to NCATS initiatives.
    • Collaborations between junior and senior investigators. For experienced investigators, utilization of junior investigator/trainees; for junior investigators, adequate/appropriate mentoring and consultation.
    • Approach Will the proposed methods achieve the aims?
    • Significance If successful will the project move the field forward? Does the proposed project answer an important translational research question?
    • Innovation Could apply to the approach, technology or its application to a novel focus.

    Additional Information


    GHUCCTS Resources for Project/Proposal Development:

    The GHUCCTS is offering free consultation services, which may be helpful to you in your proposal development.  Topic areas for advice include but are not limited t: protocol development, study design, biostatistics, feasibility assessment, recruitment plan, community engaged research best practices, integration of culturally and linguistically competent approaches, inclusion of diverse populations, etc.   Please utilize the links below for more information:

    Biostatistical Support Services

    Clinical Research Units: HU & GU

    Community Engagement Services Contact: Florencia.Gonzalez@Howard.edu

    Recruitment Services

    Protocol Development

    New requirements for funded pilot grants:

    GHUCCTS is funded through a CTSA grant from NIH's National Center for Advancing Translational Sciences (NCATS). NCATS has instituted a new policy requiring the review and approval of all GHUCCTS pilot grants involving human subjects research prior to GHUCCTS funds being utilized. Therefore, if your proposal is funded and involves research with human subjects, GHUCCTS will require additional documentation to send to NCATS. NCATS expects to complete their review in less than 30 days. The NCATS review can occur concurrently with the IRB review; however, final NCATS approval is contingent upon IRB approval

    Contact:

    Requests for information, including clarification about GHUCCTS resources available for pilot studies and questions about the preparation and submission of applications, can be obtained from the GHUCCTS PTCS administrator: Yejide Obisesan (yejide.obisesan@howard.edu; 202-806-9481)

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