ClinicalTrials.gov and FDAAA - Regulations, Policies & Guidance
This Web site provides
information to help NIH applicants and grantees (recipients of extramural
grants, including cooperative agreements) to understand their roles and
responsibilities in relation to the Food and Drug Administration Amendments Act
(FDAAA) of 2007.
The information on this site may not apply to NIH contracts or NIH
intramural research.
FDAAA for NIH Grantees: The Basics
Proposed Policies and Rules:
Proposed Rulemaking for Clinical Trials Registration and Results Submission under FDAAA
The Department of Health and Human Services published, for a 90-day public comment period, a Notice of Proposed Rulemaking (NPRM) for Clinical Trials Registration and Results Submission under Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The NPRM proposes requirements for submitting registration and summary results information, including adverse event information, for specified &applicable clinical trials& to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine, part of the National Institutes of Health (NIH). The Federal Register Notice is available for public inspection at: . Public comments should be submitted electronically by March 23, 2015 to Docket No. NIH- at .
Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
NIH is seeking public comments on a draft policy to promote broad and responsible dissemination of information on clinical trials funded by the NIH through registration and submission of summary results information to ClinicalTrials.gov. NIH encourages the public to provide comments on any aspect of the draft policy, described below, by March 23, 2015. Comments should be submitted electronically to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email at , mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or by fax at 301-496-9839.
NIH Implementation of FDAAA
( - 177 KB)
Further Resources for NIH Grantees
Additional questions about compliance
with the NIH implementation of FDAAA may be directed to the NIH Office of
Extramural Research at .
- NIH Staff Access
The NIH encourages registration and results reporting for all NIH-supported clinical trials, regardless of whether or not they are subject to FDAAA.
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外国制药企业在中国开展临床试验现况分析——基于ClinicalTrials.gov网站登记数据的统计分析.pdf4页
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外国制药企业在中国开展临床试验现况分析——基于ClinicalTrials.gov网站登记数据的统计分析.pdf
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外国制药企业在中国开展临床试验现况分析
――基于ClinicalTrials．gov网站登记数据的统计分析
姚晨1，杉野敬一2，大桥靖雄3，龚倩3
1北京大学第一医院，北京三菱田迈裂蕖株式会社，日本大阪；
3东京大学医学系研究科，日本东京
办的最新的有关临床试验的情报。通过查阅日前所登记注册临床试验的检索结果，对外国制
药企业在中国进行的独立开展或参与国际多中心临床试验登记数据进行了统计分析。结果：在中国，由制药
企业赞助的临床试验有97件，其中58件是国际多中心试验，39件是中国单独进行的试验。主要的研究对
象疾病为肿瘤、循环系统疾病、中枢系统疾病及感染。在中国单独试验中，临床试验受试药均为在海外上
市的药，这些试验的目的是为了在中国扩大适应症或是为了进口中国。而在国际多中心试验中的受试药
有在海外处于IV期，还有处于III期，这些试验的目的是为了取得中国人的试验数据或是为了促销而进
行的。在中国单独试验中有一半，在国际多中心试验中有67％是随机双盲试验。中国临床试验的特点是
参加医院数集中在10个左右。结论：外国制药企业让中国参与更多的国际多中心临床试验，加快新药研
[关键词] 国际多中心临床试验；新药研发；外国制药企业
[中图分类号]R195．1[文献标识码]A
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