CDISC has developed foundational standards over the last twenty years and published thirty-five Therapeutic Area (TA) standards and updates for the past five years in collaboration with FDA- CDER, in addition eleven TA standards are currently in development through a community-driven, consensus-based process in collaboration with CFAST organizations and the CDISC global community of reviewers. The objectives of this project are to build on existing CDISC clinical data standards to develop vasomotor symptoms due to menopause standards that span collection (CDASH), organization (SDTM), analysis (ADaM), controlled terminology, as well as develop a number of relevant Questionnaires, Ratings or Scales (QRS), using established CDISC processes and CDISC SHARE tools. CDISC will engage CFAST stakeholders as well as the CDISC global community in the development of these new vasomotor symptoms due to menopause standards. The new vasomotor symptoms due to menopause standards will bring clarity to data and support FDA in reviewing many different studies and allowing them to ?speak the same language?.
Acute Kidney Injury Project Narrative Billions of dollars are spent annually on clinical and translational research each year, yet the time to translate new findings to clinical and delivery of new drugs remains too long.[1] New approaches need to be taken to better leverage existing sources of health and research data while fostering efficacy.[2] Data from 10,000s interventional and non-interventional studies performed each year cannot be aggregated and analyzed without considerable cost, largely because the data are not collected using standard format and semantics.[3] Siloed, non- standard data leads to redundant research, where previously-published discoveries that were not highlighted in searchable abstracts indexed within Medline and by search engines are ?hidden? in non-interoperable datasets that require informatics expertise to fully mine. [4] This redundancy ultimately prolongs the process of translation to improve human health. In response, the Clinical Data Interchange Standards Consortium (CDISC) has developed standard models, concepts, terminologies and data transmission formats to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporting. The application of CDISC standards can achieve 25% time savings and between $40-260 million in cost and resource savings for stakeholders (Pharma, Academics, CROs, etc.,) (5) and facilitate bringing new treatments to patients that need them. To date, CDISC has developed Therapeutic Area (TA) standards and updates for thirty-five diseases/conditions [6], with eleven more in development through a community-driven, consensus-based process. Implementers have utilized these standards to identify biomarkers, update WHO prescribing recommendations, and improved clinical trial computerized simulations to increase the chance of success. This project proposes to leverage previous experience, governance and consensus-based standards development process to illustrate how to utilize existing CDISC clinical data standards to develop acute kidney Injury standards that span collection (CDASH), organization (SDTM), analysis (ADaM). CDISC will work with subject matter experts to develop acute kidney Injury specific Controlled Terminologies (CT); relevant Questionnaires, Ratings and Scales; and extensions to existing standards where needed. CDISC will engage CFAST stakeholders as well as the CDISC global community in the development of these new acute kidney Injury. CDISC will use innovative cloud-based tools and services to create quality controlled and SHARE machine-readable versions of these standards. The new acute kidney Injury standards will support FDA review as well as interoperability and reusability for all stakeholders.
