An Extendable Infrastructure for Building Broad Community Support Around Clinical Trials Measures

可扩展的基础设施,可围绕临床试验措施建立广泛的社区支持

基本信息

  • 批准号:
    8870486
  • 负责人:
  • 金额:
    $ 22.5万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2014
  • 资助国家:
    美国
  • 起止时间:
    2014-09-15 至 2016-08-31
  • 项目状态:
    已结题

项目摘要

PROJECT SUMMARY/ABSTRACT Data standards that define specifications for the representation and transfer of data can improve data accessibility, predictability, integration, and storage, allowing reviewers to focus on the analysis and interpretation of data. Although there are several standards for use in clinical trials, critical gaps still exist for standardizing data at the point of collection. In particular, a set of standard common data elements will improve data quality across the drug lifecycle, making it easier for CDER reviewers to compare data across different studies and adding considerable value to the larger clinical trials community and those using the results in practice and policy. The overall goal of this application is to define a set of common, standard measures and assessments and associated common data elements for use in clinical trials related to a specific therapeutic area. The strength of our research plan is an innovative, consensus-based process for first prioritizing a therapeutic area that could benefit most from common measures, identifying a set of high- quality, high-priority measures to address that therapeutic area, and then building broad-based community support for collecting those measures in studies across the drug lifecycle. Once a set of high-quality clinical research measures have been vetted with the community, we will develop an implementation guide including a set of transparent, freely available, XML-based tools to support use of the measures by the research community. Specific Aim 1: Establish an infrastructure to support broad consensus building. A Clinical Trials Research Panel (CTRP) will be established to prioritize therapeutic areas for development of standard assessments, define the criteria for selecting measures, and monitor the progress of the project. Specific Aim 2: Build broad community support around a set of high-quality, high-priority measures for use in clinical research. A Clinical Trials Working Group (CTWG) will be assembled to address the therapeutic area prioritized by the CTRP using a well-established consensus process. The CTWG will first identify a preliminary set of measures and then present those measures to the larger community for feedback and comment. Specific Aim 3: Support implementation of the prioritized measures. The measures prioritized by the CTWG will be disseminated to the community through an implementation guide that will include overarching comments from the CTWG and CTRP, a standardized set of metadata for each measure, and XML-based templates to help investigators collect data and submit results to the FDA CDER in a consistent manner.
项目总结/文摘

项目成果

期刊论文数量(0)
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Carol Marie Hamilton其他文献

Carol Marie Hamilton的其他文献

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{{ truncateString('Carol Marie Hamilton', 18)}}的其他基金

Establishing the PhenX Toolkit as a Biomedical Knowledgebase
将 PhenX 工具包建立为生物医学知识库
  • 批准号:
    10807362
  • 财政年份:
    2022
  • 资助金额:
    $ 22.5万
  • 项目类别:
Establishing the PhenX Toolkit as a Biomedical Knowledgebase
将 PhenX 工具包建立为生物医学知识库
  • 批准号:
    10707376
  • 财政年份:
    2022
  • 资助金额:
    $ 22.5万
  • 项目类别:
Linking Complex Disease and Exposure Data to Established Data Standards
将复杂疾病和暴露数据与既定数据标准联系起来
  • 批准号:
    9383531
  • 财政年份:
    2017
  • 资助金额:
    $ 22.5万
  • 项目类别:
Linking Complex Disease and Exposure Data to Established Data Standards
将复杂疾病和暴露数据与既定数据标准联系起来
  • 批准号:
    9766828
  • 财政年份:
    2017
  • 资助金额:
    $ 22.5万
  • 项目类别:
Genomic Resource Grant for the PhenX Toolkit - expansion and sustainabilityPhenX Supplement for COVID-19 Research
PhenX 工具包的基因组资源资助 - 扩展和可持续性PhenX 针对 COVID-19 研究的补充
  • 批准号:
    10179036
  • 财政年份:
    2013
  • 资助金额:
    $ 22.5万
  • 项目类别:
Genomic Resource Grant for PhenX Toolkit - expansion and sustainability: Resource Project
PhenX 工具包的基因组资源资助 - 扩展和可持续性:资源项目
  • 批准号:
    10161810
  • 财政年份:
    2013
  • 资助金额:
    $ 22.5万
  • 项目类别:
Genomic Resource Grant for PhenX Toolkit (U41)
PhenX 工具包基因组资源资助 (U41)
  • 批准号:
    8690935
  • 财政年份:
    2013
  • 资助金额:
    $ 22.5万
  • 项目类别:
Genomic Resource Grant for the PhenX Toolkit - expansion and sustainability
PhenX 工具包的基因组资源资助 - 扩展和可持续性
  • 批准号:
    10594857
  • 财政年份:
    2013
  • 资助金额:
    $ 22.5万
  • 项目类别:
Genomic Resource Grant for PhenX Toolkit (U41)
PhenX 工具包基因组资源资助 (U41)
  • 批准号:
    8728441
  • 财政年份:
    2013
  • 资助金额:
    $ 22.5万
  • 项目类别:
Genomic Resource Grant for PhenX Toolkit (U41)
PhenX 工具包基因组资源资助 (U41)
  • 批准号:
    8843280
  • 财政年份:
    2013
  • 资助金额:
    $ 22.5万
  • 项目类别:

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