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

项目总结/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、集成性和存储性，使审查人员能够专注于分析， 数据的解释。虽然有几个标准用于临床试验，但仍然存在关键的差距， 在收集数据时将数据标准化。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评审人员更容易比较 不同的研究，并增加了相当大的价值，以更大的临床试验社区和那些使用 在实践和政策中取得成果。这个应用程序的总体目标是定义一组通用的、标准的 用于临床试验的相关测量和评估以及相关的通用数据元素 具体治疗领域。我们的研究计划的优势是一个创新的，基于共识的过程， 首先优先考虑一个治疗领域，可以从共同措施中受益最多，确定一套高， 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 支持在整个药物生命周期的研究中收集这些指标。曾经一套高质量的临床 我们已就研究措施征询社会人士的意见，并会制订一份实施指引， 一组透明、免费、基于XML的工具，以支持研究使用这些指标 社区具体目标1：建立基础设施，支持建立广泛的共识。A临床试验 将建立研究小组（CTRP），以优先考虑制定标准的治疗领域 评估，确定选择措施的标准，并监测项目的进展。具体 目标2：围绕一套高质量、高优先级的临床应用措施建立广泛的社区支持 research.将组建一个临床试验工作组（CTWG）， 由CTRP使用完善的共识过程优先考虑。技术小组将首先确定一个 初步的一套措施，然后将这些措施提交给更大的社区，以获得反馈， 置评.具体目标3：支持实施优先措施。优先采取的措施 反恐工作组将通过一份实施指南向社会传播，该指南将包括 CTWG和CTRP的总体评论，每项措施的标准化元数据集，以及 基于XML的模板，帮助研究者收集数据并以一致的方式向FDA CDER提交结果 方式

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.