CDISC to Develop Data Standards for Crohn’s Disease with
Support from the Helmsley Charitable Trust
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.
Crohn’s disease is a chronic inflammatory bowel disease, with symptoms that often include severe and persistent diarrhea, nausea, and chronic pain. In the U.S., the prevalence of Crohn’s disease is rising with 201 of every 100,000 individuals suffering from the disease. In developing countries, the incidence and prevalence are increasing at an even greater rate, attributed largely to the westernization of diet and lifestyle. The currently available therapeutics and diagnostics tools do not meet the needs of patients and therefore, fail to improve the lives of people living with Crohn’s disease.
The Crohn’s disease award is part of Helmsley’s $5.6 million commitment to CDISC announced previously and will benefit the Crohn’s disease field by improving the quality, usefulness, consistency, sharing and mutual understanding of clinical data. Once developed, the clinical data standards will increase the efficiency and collaboration within research and clinical development to better address the unmet medical needs of patients. These standards will also provide the tools to further support Helmsley's data sharing priorities.
“Data sharing is central to improving the lives of Crohn’s disease patients, which remains Helmsley’s mission until a cure is found,” says Dr. Garabet Yeretssian, Director of Helmsley’s Crohn’s Disease Program. “Standardizing clinical data for Crohn’s disease will make it easier to share data across the field, and in turn, lead to better, faster, and more personalized care and treatment for people living with Crohn’s disease.”
“CDISC is honored to partner with the Helmsley Charitable Trust on this critical project,” said David R. Bobbitt, CDISC President and CEO. “Developing the first global clinical data standards for Crohn’s disease will facilitate data sharing with the greater Crohn’s disease scientific and clinical community, advancing this growing field of research.”
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 diseases. To learn more about the benefits of adopting CDISC standards, visit www.cdisc.org.
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health.
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 its active grantmaking in 2008, Helmsley has committed more than $2 billion for a wide range of charitable purposes. Helmsley’s Crohn’s Disease Program supports impactful ideas and mobilizes a global community committed to improving the lives of Crohn’s disease patients while pursuing a cure. For more information, please visit helmsleytrust.org.