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.

项目概要/摘要 定义数据表示和传输规范的数据标准可以改进数据 可访问性、可预测性、集成和存储，使审阅者能够专注于分析和 数据解释。尽管有多种临床试验使用标准，但仍存在重大差距 在收集点标准化数据。特别是，一组标准的通用数据元素将 提高整个药物生命周期的数据质量，使 CDER 审稿人更容易比较各个药物生命周期的数据 不同的研究，为更大的临床试验社区和使用该技术的人们增加了相当大的价值 实践和政策的结果。该应用程序的总体目标是定义一组通用的标准 用于与某项相关的临床试验的测量和评估以及相关的通用数据元素 特定的治疗领域。我们研究计划的优势在于一个创新的、基于共识的过程 首先优先考虑可以从共同措施中获益最多的治疗领域，确定一组高 解决该治疗领域的高质量、高度优先的措施，然后建立基础广泛的社区 支持在整个药物生命周期的研究中收集这些措施。曾经拥有一套高质量的临床 研究措施已经过社区的审查，我们将制定实施指南，包括 一套透明、免费、基于 XML 的工具，支持研究人员使用这些措施 社区。具体目标 1：建立基础设施以支持建立广泛的共识。临床试验 将成立研究小组（CTRP），优先考虑治疗领域以制定标准 评估，定义选择措施的标准，并监控项目的进展。具体的 目标 2：围绕一套用于临床的高质量、高优先级措施建立广泛的社区支持 研究。将组建一个临床试验工作组（CTWG）来解决治疗领域的问题 CTRP 使用完善的共识流程确定优先级。 CTWG 将首先确定一个 制定初步措施，然后将这些措施提交给更大的社区以获取反馈和 评论。具体目标 3：支持优先措施的实施。优先采取的措施 CTWG 将通过实施指南向社区传播，其中包括 CTWG 和 CTRP 的总体意见、每项措施的标准化元数据集，以及 基于 XML 的模板可帮助研究人员收集数据并将结果以一致的方式提交给 FDA CDER 方式。