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

• 批准号: 8870486
• 负责人: Carol Marie Hamilton
• 金额: $ 22.5万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 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
• 来源: https://reporter.nih.gov/project-details/8870486
• 关键词: Extendable; Infrastructure; Building; Broad; Community

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.

项目摘要/摘要 定义代表和传输数据规格的数据标准可以改善数据 可访问性，可预测性，集成和存储，使审阅者可以专注于分析和 数据解释。尽管在临床试验中有几种标准，但仍然存在关键差距 在收集点标准化数据。特别是，一组标准的公共数据元素将 提高整个药物生命周期的数据质量，使CDER审稿人更容易比较跨越的数据 不同的研究并为较大的临床试验社区和使用的研究增添了相当大的价值 导致实践和政策。该应用程序的总体目标是定义一组常见的标准 措施和评估以及相关的共同数据元素用于与A相关的临床试验 特定的治疗区域。我们的研究计划的优势是一个创新的，基于共识的过程 首先优先考虑可以从共同措施中受益的治疗领域，并确定一组高级措施 质量，高优先级的措施以解决该治疗领域，然后建立基于广泛的社区 支持在整个药物生命周期的研究中收集这些措施。曾经是一组高质量的临床 研究措施已与社区进行了审查，我们将制定一份实施指南 一组透明的，可免费的，基于XML的工具，以支持研究的使用 社区。特定目的1：建立一个基础设施来支持广泛的共识建设。临床试验 将建立研究小组（CTRP），以确定制定标准的治疗领域 评估，定义选择措施的标准，并监视项目的进度。具体的 AIM 2：围绕一组高质量，高优先级的措施建立广泛的社区支持 研究。将组装一个临床试验工作组（CTWG）以解决治疗区域 通过CTRP优先使用良好的共识过程。 CTWG将首先确定 初步的措施集，然后向更大的社区提出这些措施，以获取反馈和 评论。具体目标3：支持优先措施的实施。这些措施优先 CTWG将通过包括 CTWG和CTRP的总体评论，每种措施的标准化元数据集，以及 基于XML的模板，以帮助调查人员收集数据并将结果提交给FDA CDER，以一致 方式。