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.
Prostate Cancer is the number one cancer by incidence in the US, with mortality rates remaining largely unchanged over the past 30 years. A new CDISC Prostate Cancer data standard will enable data sharing and sophisticated analyses not currently available today and improve the regulatory review process for cancer clinical trials.
