Development of Prostate Cancer Standards

项目摘要 该项目的目标是开发全球性的非专有CDISC数据标准 用于前列腺癌，利用CDISC标准开发过程。复杂 由于缺乏治疗领域的数据标准，分析受到严重限制，尽管 数十亿美元投资于前列腺癌研究。 该项目的具体目标包括： ·通过现有的合作伙伴关系（如FDA、NCI）和更广泛的合作伙伴关系开展工作。 临床研究界开发前列腺CDISC数据标准 使用CDISC标准开发流程的癌症和肿瘤学[1]; ·确保与SDTM标准保持一致，以便提交监管文件， 临床试验数据收集的CDASH标准; ·通过我们与NCI企业词汇服务的长期合作伙伴关系 (EVS)，提供适用的肿瘤学研究概念， 在NCI EVS术语系统中编码的术语; ·以电子形式提供前列腺癌/肿瘤学数据标准 通过CDISC SHARE元数据存储库[2]; ·发布适用的SDTM和CDASH用户指南，并将其公开 可通过CDISC网站获得。 该项目将通过几个不同的阶段完成： ·第0阶段-启动和范围界定：审查和批准项目提案，并确定 scope. ·第一阶段-确定研究概念：创建多学科核心团队 （包括FDA联系人），审查现有的前期工作，设计概念图，并执行 与现有CDISC结构的差距分析。 ·第2阶段-制定标准草案：核心团队制定详细的元数据， SDTM格式的SHARE，用户指南草案。 ·第3.1阶段-内部审查：由相关CDISC团队审查标准草案， 前列腺癌的治疗方法 ·第3.2阶段-公众审查：由公众对标准草案进行审查， 30天内，批准为最终生产标准。 ·阶段3.3 -公开发布：数据标准发布到CDISC网站。

Project Summary The objective of this project is to develop global, non-proprietary CDISC data standards for Prostate Cancer, utilizing the CDISC standards development process. Sophisticated analyses are severely limited by the lack of therapeutic area data standards, despite the billions of dollars invested in Prostate Cancer research. The Specific Aims of this project include: · Working through existing partnerships (e.g. FDA, NCI) and with the broader clinical research community to develop CDISC data standard(s) for Prostate Cancer and Oncology using the CDISC standards development process [1]; · Ensuring alignment with the SDTM standard for regulatory submissions and CDASH standard for data collection in clinical trials; · Through our long-standing partnership with NCI Enterprise Vocabulary Services (EVS), providing applicable oncology research concepts and controlled terminology coded in the NCI EVS terminology system; · Providing the Prostate Cancer / Oncology data standard in electronic form through the CDISC SHARE metadata repository [2]; · Publishing applicable User Guides for SDTM and CDASH, making them publicly available through the CDISC website. This project will be accomplished through several distinct stages: · Stage 0 – Initiation and Scoping: Review and approval of project proposal and define scope. · Stage 1 – Identification of Research Concepts: Create multi-disciplinary core team (including FDA contact), review available prior work, design concept maps, and perform gap analysis with existing CDISC constructs. · Stage 2 – Development of Draft Standards: Core team develops detailed metadata for SHARE in SDTM format, draft user guide. · Stage 3.1 – Internal Review: Review of draft standards by relevant CDISC teams and experts in Prostate Cancer. · Stage 3.2 – Public Review: Review of draft standards by general public for a minimum of 30 days, approve as a final production standard. · Stage 3.3 – Public Release: Data standard posted to CDISC website.