Alzheimer’s disease researchers now have the ability to access a database of more than 4,000 patients with the condition who have participated in 11 industry-sponsored clinical trials, the Coalition Against Major Diseases announced June 11.
The database of combined clinical trials is the first to be openly shared by pharmaceutical companies and made available to qualified researchers.
The CAMD is a consortium of 12 pharmaceutical companies, research foundations (CHDI Foundation Inc. and Parkinson’s Disease Foundation), and patient advocacy/voluntary health organizations (Alliance for Aging Research, Alzheimer’s Association, Alzheimer’s Foundation of America, National Health Council, and Parkinson’s Action Network). The coalition also includes advisers from the U.S. Food and Drug Administration, the European Medicines Agency, the U.S. National Institute of Neurological Disorders and Stroke, and the U.S. National Institute on Aging. The FDA is a sponsor of the U.S.-based Critical Path Institute, which leads and manages the CAMD.
In a statement, the coalition said it hopes to use this effort as a model for a voluntary industry data standard that will help to accelerate research into new treatments for other neurodegenerative diseases, such as Parkinson’s disease and Huntington’s disease, and to predict their true course.
The availability of the database will allow researchers to improve the efficiency of clinical trials in demonstrating whether a treatment is safe and effective, and to find biomarkers that identify patients with Alzheimer’s disease and Parkinson’s disease “before symptoms are apparent,” according to CAMD director, Dr. Marc Cantillon.
In future submissions of new drug applications to the FDA, the pharmaceutical companies that are members of the CAMD will now use common data standards for Alzheimer’s disease that have been established by the nonprofit, standard-setting organization for clinical research data called the Clinical Data Interchange Standards Consortium.
The database will not include patient identifiers in order to protect their privacy.
Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
防治重大疾病联盟(CAMD)于6月11日宣布，阿尔茨海默病的研究者们现在能够访问一个纳入超过4,000例该病患者的数据库，这些患者是由制药业赞助的11项临床试验的受试者。
这一由多项临床试验联合组成的数据库是在制药公司间公开共享的首个数据库，且该数据库还对符合条件的研究者开放。
CAMD是由12家制药公司、研究基金会(CHDI基金会公司和帕金森病基金会)和患者倡导/志愿健康组织(老龄化研究联盟、阿尔茨海默病协会、美国阿尔茨海默病基金会、国民健康局和帕金森行动网)组成的联盟。该联盟还包括来自美国食品药品管理局(FDA)、欧洲药品管理局(EMA)、美国国立神经疾病与卒中研究院和美国国立老化研究所的顾问。FDA是美国关键路径研究所的赞助方之一，该机构负责领导并管理CAMD。
该联盟在一项声明中宣称，其希望在构建自愿性行业数据标准的过程中将该模式作为典范加以推广，这一标准的出台将有助于加速研发用于其他神经退行性疾病(譬如帕金森病和亨廷顿病)的新治疗方案，并预测这些疾病的真实进程。
开放该数据库将使研究者得以提高临床试验的效率，以阐明某种疗法是否安全有效，并找到那些能“在明显症状出现前”鉴别出阿尔茨海默病和帕金森病患者的生物标志物，据CAMD负责人Marc Cantillon博士介绍说。
如果在未来需要向FDA提交新药申请，则那些属于CAMD成员的制药公司将使用 阿尔茨海默病的共用数据标准，该标准由专门处理临床研究数据的非盈利性标准制定组织(其名为“临床数据交换标准协会”)制定。
为了保护受试患者的隐私，该数据库将不会收录患者的个人标识信息。
爱思唯尔 版权所有
