The National Institute of Neurological Disorders and Stroke (NINDS) encourages applications for clinical trial planning grants. This announcement is made together with 7 other components of the National Institutes of Health (NIH).*
The purpose of the NIH Clinical Trial Planning Grant (R34) is to provide support for the development of a phase III clinical trial, including the establishment of the research team, the development of tools for data management and oversight of the research, the definition of recruitment strategies, and the finalization of the protocol and other essential elements of the study included in a manual of operations/procedures. The clinical trial planning grant is not designed for collecting preliminary data or conducting pilot studies to support the rationale for a clinical trial.
An NIH-defined phase III clinical trial is a broadly based prospective clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often, the aim of such an investigation is to provide a scientific basis for consideration of a change in health policy or standard of care.
Activities supported by the R34 grant may include, but are not limited to: developing or finalizing the manual of operations; finalizing plans for addressing federal and NIH gender/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 or finalizing safety and monitoring plans; and developing plans for training that may be required to carry out the proposed trial, including, for example, training of data collectors and individuals who will carry out the planned intervention.
For more information, potential applicants should contact Dr. Scott Janis, Program Analyst, Clinical Trials Cluster, NINDS, Neuroscience Center, 6001 Executive Boulevard, Room 2210, Bethesda, MD 20892; telephone: 301-594-0211; fax: 301-480-1080; e-mail: email@example.com.
*For a full list of supporting NIH components and a more detailed description of this program announcement, please visit the NIH web site at: http://grants.nih.gov/grants/guide/pa-files/PA-04-008.html.