TUCSON, Ariz. and AUSTIN, Texas — 15 October, 2019 — The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Foundational Standard that describes how to represent data for the natural history and efficacy studies conducted in animals submitted to applications under the U.S. Food and Drug Administration (FDA) regulations commonly known as the Animal Rule. The Animal Rule provides a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.
Austin, TX – 18 Sep 2019 – CDISC is pleased to announce the first release of a global Therapeutic Area Standard using Traditional Chinese Medicine. Specifically, the standard describes how to use CDISC standards to represent data pertaining to coronary artery disease for the treatment of angina. Released in the form of a User Guide for data managers, statisticians, programmers and study managers, the standard is freely available on the CDISC website.
Austin, TX – 28 Aug 2019 – CDISC congratulates Bron Kisler, a founder of CDISC and long-time executive, on being elected Chair of the ISO/TC 215 Genomics Sub-Committee. Kisler was unanimously elected by 30 member countries from across Asia, Australia, Europe and the Americas. This newly launched Sub-Committee (SC) will standardize genomics data globally across ISO-member nations and beyond. The scope of the Genomics SC is “Standardization of computable data, information, and knowledge, including their representation and metadata, for the application of omics, including but not limited to genomics, transcriptomics and proteomics, to support human health and clinical research.”
MANHATTAN BEACH, CA and AUSTIN, TX – 27 Aug 2019 – The Pancreatic Cancer Action Network (PanCAN), the leading pancreatic cancer patient advocacy organization, and CDISC, the global nonprofit dedicated to developing and advancing clinical research data standards of the highest quality, announced today a collaboration to establish the first-ever data standards specifically for pancreatic cancer.
AUSTIN, TX and TUCSON, AZ – 02 May 2019 — CDISC and The Critical Path Institute (C-Path) are pleased to announce the release of a global Therapeutic Area Standard, which describes how to use CDISC standards to represent data in research studies pertaining to Clostridium difficile associated diarrhea (CDAD).
AUSTIN, TX and TUCSON, AZ – 16 Apr 2019 – CDISC and the Critical Path Institute (C-Path) are pleased to announce the release of a global Therapeutic Area Standard that specifies how to structure commonly collected data and outcome measurements in clinical trials for HIV. The standard, released in the form of User Guide for data managers, statisticians, programmers and study managers, covers the areas of prevention, vaccines and treatment and is freely available on the CDISC website.
Austin, TX and New York, NY – 02 Apr 2019 – CDISC will develop the first global, non-proprietary clinical data standards for Crohn’s disease with a grant award of $1 million from The Leona M. and Harry B. Helmsley Charitable Trust. CDISC Standards specify how to structure data to expedite approval of new therapeutics and enable data sharing, cross-study comparisons, and meta-analyses. Consistent data structure supports the automated flow and meaningful exchange of data between all stakeholders including clinicians, researchers, pharmaceutical companies and regulatory authorities.