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Austin, TX – 15 AUG 2017 – According to the World Health Organization, prostate cancer is one of the five most common types of cancer to affect men globally. In an effort to improve research for prostate cancer, the Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the release of a new Therapeutic Area (TA) Standard for Prostate Cancer in the form of a User Guide for data managers, statisticians, programmers and study managers. In announcing the new CDISC Therapeutic Area User Guide, freely available on the CDISC website, President and CEO David R. Bobbitt stated, “CDISC’s community has built this Therapeutic Area Standard to provide research professionals with guidance on how to represent patient data in clinical research to improve quality, efficiency and cost effectiveness, fostering smarter research to discover new treatments. By building data standards for researchers, we give them a more rapid start up and the capacity to share data with collaborators with less effort.”

Austin, TX – 27 July 2017 – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the availability of a new Therapeutic Area Standard for Diabetic Kidney Disease in the form of a User Guide for data managers, statisticians, programmers and study managers, which is freely available on the CDISC website. Therapeutic Area User Guides provide research professionals with guidance on how to represent patient data in clinical research to improve quality, efficiency and cost effectiveness, enabling smarter research to unlock cures.

This manuscript, published in the International journal of Medical Informatics, describes the development, validation and evaluation of a real-world clinical trial, embedded in primary care Electronic Health Record Systems and using CDISC standards. This real-world trial is a first; only 'proof of principal pilots' have been conducted until now.

As a stakeholder with an interest in the future of CDISC, you have the opportunity to participate in the process of nominating candidates for the CDISC Board of Directors. There will be two Board seats opening up with terms beginning 01 Jan 2018.

Nominations must be submitted via email to nominations@cdisc.org by 30 June 2017.

TUCSON, Ariz., and AUSTIN, Texas – June 13, 2017The Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path) announce the availability of a Duchenne muscular dystrophy therapeutic area user guide (TAUG-DMD v1.0) for public review. The review period for the TAUG-DMD v1.0 began on May 8, 2017, and runs through July 6, 2017. Qualified researchers and clinicians are encouraged to review TAUG-DMD v1.0 and offer feedback.

Austin, TX – 08 June 2017 – Today, David R. Bobbitt, President and CEO at Clinical Data Interchange Standards Consortium (CDISC), appointed Shannon Labout CDISC’s Interim Chief Standards Officer. A collaborative leader, dedicated educator, and Certified Clinical Data Manager (CCDM), Ms. Labout has a proven track record of creating, leading and growing successful organizations in clinical data management, standards implementation and training. In her new role, she will guide the future of standards development, working with CDISC leadership, partners, members and volunteer teams. She will also continue to serve as CDISC’s VP of Education.

CDISC served as a key stakeholder, providing input to the development of Common Protocol Template (CPT). CPT aligns with NIH/FDA-developed Template connecting the parallel universes of clinical care and research as stated by FDA Commissioner during the CDISC/FDA strategy session in August 2016.