AUSTIN, Texas--(BUSINESS WIRE)--The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce it has been awarded a grant in the amount of $1,000,000 by The Leona M. and Harry B. Helmsley Charitable Trust to develop Type 1 Diabetes (T1D)-related data standards.
In the U.S. alone, over 1.5 million people live with this disease and approximately 30,000 people are diagnosed every year. “Helmsley is dedicated to improving the lives of all people living with T1D,” said Gina Agiostratidou, Program Director of Helmsley’s Type 1 Diabetes Program. “Tools that facilitate standardized clinical trials and studies are enabling crucial data sharing and are essential to achieving our goal.”
The Helmsley grant will make possible the development of new T1D CDISC standards that will extend published diabetes standards by developing machine-readable metadata in the following focus areas: Pediatrics, Devices, Prevention, and Exercise. Continuing its longstanding partnership with Critical Path Institute (C-Path), CDISC will work with C-Path to pilot the utility of draft standards in aggregating large datasets during the development process. These standards will make it easier for all stakeholders (clinicians, researchers, drug development companies, and regulatory authorities) to share and compare data to evaluate the effectiveness of emerging T1D treatments.
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 studies around the globe. This will enable researchers to develop meaningful insights, discover new treatments, and find breakthroughs. The suite of CDISC standards is freely available on the CDISC website.
“Diabetes is a ravaging disease that has affected many of our family and friends,” said David R. Bobbitt, President and CEO, CDISC. “Type 1 Diabetes is a particularly pernicious challenge for many children and families across the globe. CDISC standards serve an integral role in research by bringing clarity to the data. Our work allows for more collaborations and unlocks greater impact of research dollars, a virtuous cycle underscoring that researchers, patients, clinicians, and funders of research like the Helmsley Charitable Trust are clearly stronger together.”
CDISC standards have been adopted and used in more than 90 countries, and are required by regulatory authorities in the US and Japan. To date, Therapeutic Area Standards have been developed for more than 30 different disease areas. Use of these standards from the start of clinical research programs has proven capable of saving both time and resources. Researchers in the T1D space will be able to freely implement these standards into their processes.
CDISC is a 501(c)(3) global, non-profit organization that develops data standards to foster smarter research. CDISC standards have been adopted and used in more than 90 countries and 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). CDISC is funded through the generous support of over 450 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.org.
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the US Food and Drug Administration (FDA). C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established global, public-private partnerships that currently include over 1,450 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona. For more information, visit www.c-path.org.
About The Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $2 billion for a wide range of charitable purposes. For more information, visit www.helmsleytrust.org.