Notice Number: NOT-NS-13-030

Key Dates
Release Date: June 14, 2013
Estimated Publication Date of Announcement: August 2013
First Estimated Application Due Date: October 2013
Earliest Estimated Award Date: March 2014
Earliest Estimated Start Date: May 2014

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) intends to issue a Funding Opportunity Announcement (FOA) to solicit applications for the NINDS Clinical Research Methods Course. The goal of this initiative is to enhance the training of new investigators in the conduct of high-quality clinical trials.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in summer 2013 with an expected application due date in Fall 2013.

This FOA will utilize the R25 activity code. Details of the planned FOA are provided below.

Research Initiative Details

The NINDS Clinical Research Methods in Clinical Neurological Disorders course will use the R25 grant mechanism to support an educational course for faculty in any clinical neuroscience subspecialty and introduce them to the principles of good clinical trial design by exposing early career clinical scientists to the full spectrum of challenges in clinical research. The NINDS aims to develop a cadre of well-trained researchers whose expertise will foster better clinical study design and thereby lead to improved regimens for therapy and prevention of neurological disorders.

It is anticipated that this annual course will yield a group of talented, dedicated clinical neuroscience researchers who will consequently be in a position to obtain funding for their own high quality clinical research. If the program is successful, it is anticipated that participant scholars will return to their organizations/institutions where they will take a prominent role in advancing local clinical research priorities in neurology. To achieve this objective, NINDS requires a high-impact program for enhancing the training of future researchers that is innovative and that exceeds other training experiences available to those treating neurological disease. An important part of the NINDS extramural clinical trials budget is spent on early phase trials (phase 1, 2, and pilot trials) so that the primary focus of this grant is on training in early phase clinical trials.

Specific performance goals of the FOA are:

• To develop the scientific content, curriculum, and format of a comprehensive, hands-on educational program incorporating innovative methods of teaching and conducting clinical research and taking advantage of knowledge gained in disciplines outside of neurology, with emphasis on proof of principle studies for new therapeutic agents, validating biomarkers for use in early phase clinical trials.
• To organize and conduct the educational program, including recruitment and selection of faculty and participants.
• To conduct formal evaluation of the program and, where relevant, incorporate results into subsequent course offerings.
• To maximize the course impact by making the didactic material available online for the additional benefit of a wider audience.

It is expected that the grant tasks will be performed in two phases. Phase I comprises the development of the education program; Phase II includes conducting each iteration of the course and course evaluation.

Inquiries

Please direct all inquiries to:

Robin Conwit, MD
Program Director
Office of Clinical Research
National Institute of Neurological Disorders and Stroke
Telephone: (301) 496-9135
Fax: (301) 410-1080
Email: Robin.Conwit@nih.gov