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，使审查者能够专注于分析和 数据的解释。尽管在临床试验中使用了几个标准，但仍然存在关键的差距 在采集点对数据进行标准化。具体地说，一组标准公共数据元素将 提高药物生命周期中的数据质量，使CDER审查者更轻松地比较数据 不同的研究，并为更大的临床试验社区和使用 在实践和政策中取得成效。该应用程序总体目标是定义一组通用的、标准的 用于临床试验的测量和评估以及相关的公共数据元素 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 首先确定可以从常见措施中受益最大的治疗领域，确定一组高质量的 高质量、高优先级的措施来解决这一治疗领域，然后建立基础广泛的社区 支持在药物生命周期的研究中收集这些措施。曾经一套高质量的临床 我们已与社会各界共同审阅研究措施，并会制订一份实施指引，包括 一套透明的、免费可用的、基于XML的工具，以支持研究人员使用这些措施 社区。具体目标1：建立支持广泛建立共识的基础设施。一项临床试验 将成立研究小组(CTRP)，以确定制定标准的治疗领域的优先顺序 评估，定义选择措施的标准，并监测项目的进展。特定的 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 反恐方案利用既定的协商一致进程确定优先事项。CTWG将首先确定一个 一套初步措施，然后将这些措施提交给更大的社区，以获得反馈和 评论。具体目标3：支持执行优先措施。这些措施的优先顺序是 CTWG将通过一份执行指南向社区传播，该指南将包括 来自CTWG和CTRP的总体意见，每项措施的一套标准化元数据，以及 基于XML的模板，帮助调查人员收集数据并将结果以一致的方式提交给FDA CDER 举止。