AUSTIN, Texas & NEW YORK–(BUSINESS WIRE)–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.
About CDISC
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.
Contacts
Ann P. White
+1.512.363.5826
awhite@cdisc.org