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.
We kicked this project off in April 2018 and invite you to listen to the webinars to learn more about how the Helmsley Trust and CDISC are working together.