NINDS Clinical Trial Methods in Clinical Neurological Disorders Course (R25 Clinical Trial Not Allowed)

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.

Application Instructions

Please submit:

1. A one‐page letter of intent with a description of proposed aims and approach.
2. If the final application requires a diversity statement or statement of broader impacts, please summarize your plans to address the specific requirements on an additional page.
3. CV (not biosketch) of the PI.

to limitedsubs@uw.edu by 5:00 PM Wednesday, September 13, 2023. Proposals are due to the sponsor 10/23/2023 so you will need to have your materials in to the Office of Sponsored Programs by 10/12/2023 if given the go‐ahead by the Limited Submissions review committee.