The National Institute of Neurological Disorders and Stroke (NINDS) encourages applications for clinical trial planning grants. This announcement is made together with 9 other components of the National Institutes of Health (NIH).*
An NIH-defined phase III clinical trial is a broadly based prospective clinical investigation-usually involving several hundred or more human subjects-that evaluates an experimental intervention by comparing it with a standard or control intervention, or that compares two or more existing treatments. Often, the aim of such investigation is to provide evidence leading to a scientific basis to consider a change in health policy or standard of care.
The purpose of NIH clinical trial planning grants is to provide support for the development of a phase III clinical trial, including establishment of the research team, development of tools for data management and oversight of the research, definition of recruitment strategies, and finalization of the protocol and other essential elements of the study included in a manual of operations/procedures (MOP).
Activities supported by this funding initiative include, but are not limited to: developing and finalizing the MOP; finalizing plans for addressing federal and NIH gender and minority inclusion and human subjects protection requirements; establishing collaborative arrangements; instituting means to assure standardization of procedures across sites and among staff; developing tools needed for data collection and management; developing and finalizing safety and monitoring plans; and developing plans for training that may be required to carry out the proposed trial.
For more information, potential applicants should contact Dr. Scott Janis, Clinical Research Project Manager, Clinical Trials Group, NINDS, Neuroscience Center, 6001 Executive Boulevard, Room 2191, Bethesda, MD 20892; telephone: 301-496-9135; fax: 301-480-1080; e-mail: firstname.lastname@example.org.
For a full list of supporting NIH components and a more detailed description of this announcement, please visit the NIH web site at: http://grants.nih.gov/grants/guide/pa-files/PA-06-363.html.