As of 2014, an estimated 422 million people around the world were afflicted with diabetes. Among them, approximately 25 percent will also suffer from related diabetic kidney disease. Diabetic kidney disease is the most common cause of end-stage renal disease (i.e., kidney disease severe enough to require treatment with dialysis or transplantation) and is increasing in prevalence, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the U.S. National Institutes of Health.
“With an increasing number of therapies in development for diabetic kidney disease this is an exciting time, which highlights the importance of data standards which will facilitate the exchange of information and bringing them into clinical practice,” said Richard Haynes, Associate Professor at the MRC Population Health Research Unit, University of Oxford and co-chair of the Kidney Health Initiative’s expert advisory group, which contributed to the development of the guidelines.
“This data standards effort brought together academia, regulatory, consortia, industry and non-profit organizations,” said Rachael Zirkle, data sciences and solutions transformation advisor at Eli Lilly and Company. “Our focus was on delivering a much-needed guide that will help drive diabetic kidney disease research forward.”
This CDISC Therapeutic Area User Guide was developed with support from the Kidney Health Initiative, a public-private partnership by the American Society of Nephrology (ASN) and U.S. Food and Drug Administration (FDA) and the Coalition For Accelerating Standards and Therapies (CFAST) initiative, a partnership of CDISC and the Critical Path Institute (C-Path), with participation from the U.S. NIH National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), FDA, TransCelerate, the Japan Pharmaceutical and Medical Devices Agency (PMDA) and other stakeholders to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health.
CDISC standards have been adopted and used in more than 90 countries, and are required for submissions to the U.S. FDA and Japan PMDA. To date, Therapeutic Area standards have been developed for over 30 disease areas.
CDISC is a 501(c)(3) global, non-profit organization that develops data standards to foster smarter research and enable connections to healthcare. CDISC standards allow data to speak the same language, by providing common formats for data collection, data sharing and data analyses to make the most of the valuable information offered by patients participating in research studies around the globe, enabling researchers to discover new treatments, find breakthroughs, and unlock cures. CDISC standards are required for regulatory submissions to the U.S. FDA and Japan PMDA, endorsed by the China CFDA, and requested for use by the European Innovative Medicines Initiative (IMI). The suite of CDISC standards is freely available on the CDISC website.
CDISC is funded through the generous support of over 400 member organizations from pharmaceutical, biotech, clinical research organizations, regulatory agencies, academia, and healthcare, as well as through grants, authorized CDISC Education courses, events and charitable contributions. To find out more about how to support CDISC and get involved, please visit www.cdisc.organd www.unlockcures.org.
About TransCelerate BioPharma Inc.
TransCelerate BioPharma Inc. is a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organization’s mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. TransCelerate evolved from conversations at various forums for executive R&D leadership to discuss current issues facing the industry, and examine solutions for addressing agreed-upon common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Amgen, Astellas Pharma Inc., EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Merck & Co., Inc., Novo Nordisk, Shionogi & Co., Ltd. and UCB.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research & Development operations. Executive offices are located in Conshohocken, PA. For more information, please visit http://www.transceleratebiopharmainc.com.