title: Funding evidence: the National Institute of Neurological Disorders and Stroke Clinical Trials Program.
abstract: The goal of the National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Program is to foster clinical trials that will provide the evidence needed to inform clinical care. The NINDS currently supports clinical research in over 150 neurological disorders. The rapid pace of preclinical discovery and the diversity of neurological diseases, however, present challenges for clinical trials. There is a growing number of potential interventions to be tested in clinical trials. The NINDS Clinical Trials program is therefore exploring ways of making drug selection for clinical trials more evidence-based. Additionally, NINDS supports pilot clinical trials that focus on the timely and efficient testing of agents to determine if resource-intensive comparative efficacy trials are warranted. In concert with the National Institutes of Health Roadmap, NINDS is planning to expand clinical trials infrastructure. This infrastructure is intended to enable the conduct of clinical trials for rare diseases and diseases without previous trials experience and facilitate the recruitment of a broad range of participants. Rigorous programs to select agents, and design and monitor clinical trials will encourage the efficient use of this clinical trials infrastructure and will ensure that NINDS-funded studies meet the highest scientific and ethical standards.
authors.affiliation: National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland 20892, USA. ravinab@ninds.nih.gov
authors.forename: Bernard
authors.initials: B
authors.lastname: Ravina
authors.forename: Scott
authors.initials: S
authors.lastname: Janis
authors.forename: Julianna
authors.initials: J
authors.lastname: Keleti
authors.forename: John M
authors.initials: JM
authors.lastname: Marler
mesh_terms: D000047:Academies and Institutes / Q000458:organization & administration / Q000592:standards*; D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D009422:Nervous System Diseases / Q000628:therapy*; D012107:Research Design / Q000592:standards; D020521:Stroke / Q000628:therapy
references.citation: Arch Neurol. 2000 Oct;57(10):1430-6
references.pmid: 11030794
references.citation: Neurology. 2003 Apr 22;60(8):1234-40
references.pmid: 12707423
references.citation: BMJ. 2002 Jun 22;324(7352):1508-11
references.pmid: 12077043
references.citation: JAMA. 2002 Jul 17;288(3):358-62
references.pmid: 12117401
references.citation: Trends Neurosci. 2002 Oct;25(10):494-6
references.pmid: 12220871
references.citation: Nat Neurosci. 2002 Nov;5 Suppl:1023-5
references.pmid: 12403975
references.citation: Nat Neurosci. 2002 Nov;5 Suppl:1027-9
references.pmid: 12403977
references.citation: Nat Neurosci. 2002 Nov;5 Suppl:1029-30
references.pmid: 12403978
references.citation: JAMA. 2003 Mar 12;289(10):1278-87
references.pmid: 12633190
references.citation: Science. 2003 Oct 3;302(5642):63-72
references.pmid: 14526066
references.citation: N Engl J Med. 2003 Nov 6;349(19):1860-5
references.pmid: 14602885
references.citation: Biometrics. 1979 Dec;35(4):775-83
references.pmid: 526523
references.citation: Stat Med. 1993 Mar;12(5-6):419-24
references.pmid: 8493420
references.citation: N Engl J Med. 1995 Dec 14;333(24):1581-7
references.pmid: 7477192
references.citation: Cancer Res. 1998 Oct 1;58(19):4211-6
references.pmid: 9766639
references.citation: N Engl J Med. 2001 Mar 8;344(10):710-9
references.pmid: 11236774