Slots: 1
Deadlines
Internal Deadline: Contact RII.
LOI: 30 days prior to the application due date
External Deadline: October 23, 2023
Award Information
Award Type: Grant
Estimated Number of Awards: 1
Anticipated Award Amount: $250,000/year
Who May Serve as PI: Standard NIH requirements.
Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-23-030.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here: RII Limited Submission Applicant Template
Materials to submit include:
- (1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
Purpose
The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.
The overarching goal of this R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.
Despite recent breakthroughs in neuroscience there are thousands of neurological disorders that still cause significant mortality and disability. There is an urgent need to continue to improve the efficiency of rigorous clinical trials in order to explore new therapeutic avenues. Effective training of researchers new to clinical trials is essential to promote successful and rigorous clinical trials to ultimately decrease burden of global neurological diseases.
The purpose of the “Clinical Trial Methods in Neurological Disorders Course” Notice of Funding Opportunity (NOFO) is to support educational activities in the mission areas of NINDS. The overarching goal of this R25 is to attract investigators who are new to or with limited exposure to clinical research, promote training of this workforce with the long-term goal of increasing the reliability and effectiveness of clinical trials by 1) introducing the principles of good clinical practice to investigators in any clinical neuroscience subspecialty, thereby providing a foundation for scientifically rigorous and ethical performance of patient oriented clinical research 2) exposing early career clinical scientists to the challenges and potential solutions to overcome these challenges in clinical research and, 3) increasing the number and expertise of knowledgeable clinical research investigators in the workforce to enhance the pipeline of scientifically sound, well-designed clinical trials. Long term, the development of well-trained, experienced clinical researchers with expertise will foster better clinical trials design and thereby hasten the introduction of improved regimens for therapy and prevention of neurological disorders into everyday medical practice and patient care.
To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on:
Courses for Skills Development: The goal of this activity is to support a clinical trial methodology course to train a group of talented, dedicated clinical neuroscience researchers to enable them to obtain external funding in the future. Key components of the course include a program of didactic lectures, individual or group projects, discussion sessions, and mentoring sessions. The award will provide support for expenses for the implementation of the course in each year, including travel for all non-government course participants (faculty, advisors, and scholars) and all necessary materials and facilities, including meeting space, computer access, virtual meeting platform and course materials.
Research Experiences: An emphasis on early phase (i.e., phase I /II or pilot) trials within the mission areas of NINDS is essential, including pediatrics and rare diseases to address the full spectrum of neurological disorders. Developing trial designs for early phase trials are especially challenging yet critical to inform future scientific steps. A major component of the educational course is expected to be small group protocol development sessions and individual one-on-one mentoring sessions with faculty, as well as outreach/engagement in the community to learn crucial aspects of trial development and potential recruitment. At the conclusion of the course, participant scholars should have developed a sound clinically relevant and feasible clinical trial protocol.
This NOFO aims to provide support for research education projects focused on clinical trial methodology in neurological disorders that are novel, innovative and designed to accomplish a specific goal based on a well-conceived evaluation plan. Applications will be expected to include a detailed plan to evaluate the effectiveness of the activities proposed and to include a plan for disseminating results of this program.
Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.