NINDS Guidelines for Enrollment of Subjects into NINDS-Funded Clinical Trials

Notice Number: NOT-NS-05-010

Key Dates
Release Date: August 18, 2005

Issued by
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

The purpose of this notice is to inform NINDS grant applicants that beginning with the February 1, 2006 grant submission cycle, research proposals of biomedical or behavioral interventions submitted as a NINDS pilot clinical trial (http://grants.nih.gov/grants/guide/pa-files/PAR-03-174.html), or as a multi-center clinical trial, must include relevant information that addresses the feasibility of recruiting subjects who are eligible for the clinical trial. Specifically, potential applicants must provide evidence that each recruiting center in the trial has access to a sufficient number of study participants who meet the eligibility criteria as defined in the submitted protocol. For multi-site applications, information must be provided for each site participating in the trial.

Examples of relevant information may include (but are not limited to) data summarized from patient registries or chart reviews (including data within 2 years of the submitted application), prospectively collected data from patients presenting in the clinic, or enrollment of subjects into a previous study with a similar protocol. In addition the applicants should describe their experience in enrolling subjects in other clinical trials (including experience in enrolling minority populations) and their track record for meeting study enrollment goals in a timely fashion. The proposed application should provide specific information concerning the potential number of eligible subjects available at each participating site but this data should not have identifiers that could be linked to patients. These estimates should take into account any competing study(s) being performed at each clinical site that could impact the recruitment of subjects into the proposed trial. A plan for enrolling eligible participants into competing studies should be described in the application.

A summary of the potential subject enrollment information should be included in the 25 page research plan of the application. Site-specific subject availability data may be provided in detail in supplemental appendix pages as needed. Applications covered by this policy that do not include this subject eligibility information will be viewed as incomplete and returned to the applicant without a review.

Inquiries

For additional information about programs covered by this policy see the following url: http://www.ninds.nih.gov/funding/research/clinical_research/index.htm. Any further questions regarding these guidelines should be addressed to:

Scott Janis, Ph.D.
National Institute of Neurological Disorders & Stroke
National Institutes of Health
6001 Executive Boulevard, Rm. 2209, MSC 9525
Bethesda, MD 20892-9525
Phone: (301) 496-9135
FAX: (301) 480-1080
Email: sj151t@nih.gov


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