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Applicability of NINDS-sponsored studies to community-based physician involvement

From The EMMES Corporation (A.S.L., T.C., R.W.L.), Rockville, MD; Quality Research Systems (R.S.), Chicago, IL; University of Florida (K.J.M.), Gainesville; and The National Institute of Neurological Disorders and Stroke (J.C.O., R.G.H.), Bethesda, MD.

Address correspondence and reprint requests to Dr. Anne Lindblad, CRC Operations Center, 401 N. Washington Street, Suite 700, Rockville, MD 20850 alindblad{at}emmes.com

Background: The National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Group established the Clinical Research Collaboration (CRC) Project in 2005 to increase community-based physician involvement in NINDS-sponsored research.

Methods: We assessed a random sample of 112 of the more than 1,000 current NINDS-sponsored clinical research studies to determine which could involve community physicians in enrollment or follow-up. Scoring factors were based on the premise that participation is feasible for noninvasive studies with simple screening, and follow-up criteria and visit frequency consistent with usual care. Scored studies included 26 Phase III, 31 Phase I/II, and 55 nonclinical trials.

Results: Overall, 41% of the sampled research studies were considered conducive to community physician participation that exceeds referral only; 21% with participation in all study activities and 20% with ability to provide some follow-up. Specialized neuropsychological or neurologic scale testing was judged to exclude community physician participation in 16% of studies.

Conclusion: Many National Institute of Neurological Disorders and Stroke studies are available in which community-based physicians could participate. Involving community physicians may increase efficiency of completing clinical research and encourage application of research findings in community practices.

Abbreviations: CRC = Clinical Research Collaboration; NINDS = National Institute of Neurological Disorders and Stroke.

Editorial, page 1656.

e-Pub ahead of print on December 5, 2007, at www.neurology.org.

Supported by NINDS Contract HHSN265200523641C.

Disclosure: The authors report no conflicts of interest.

Received February 2, 2007. Accepted in final form July 9, 2007.

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