Ravina Bernard, Janis Scott, Keleti Julianna, Marler John M
National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland 20892, USA.
NeuroRx. 2004 Jul;1(3):317-22. doi: 10.1602/neurorx.1.3.317.
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.
美国国立神经疾病与中风研究所(NINDS)临床试验项目的目标是推动开展临床试验,以提供指导临床护理所需的证据。NINDS目前支持针对150多种神经系统疾病的临床研究。然而,临床前发现的快速发展以及神经系统疾病的多样性给临床试验带来了挑战。有待在临床试验中测试的潜在干预措施越来越多。因此,NINDS临床试验项目正在探索使临床试验药物选择更具循证性的方法。此外,NINDS支持开展试点临床试验,重点是对药物进行及时、高效的测试,以确定是否有必要开展资源密集型的对比疗效试验。与美国国立卫生研究院路线图一致,NINDS正计划扩大临床试验基础设施。该基础设施旨在能够开展针对罕见病和此前无试验经验疾病的临床试验,并便于招募广泛的参与者。严格的药物选择、临床试验设计及监测项目将促进对该临床试验基础设施的高效利用,并确保由NINDS资助的研究达到最高的科学和伦理标准。