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CDISC and the National Organization for Rare Disorders (NORD®) have announced a partnership to develop global data standards for rare diseases. The data standards will be released in a Therapeutic Area User Guide that will be available at no cost on the CDISC website for researchers to leverage in studies to maximize data’s full potential.

According to the FDA, any disease, disorder, illness or condition affecting fewer than 200,000 people in the United States is considered rare. There are approximately 7,000 rare diseases and it’s estimated that 25-30 million Americans have rare diseases. More than 90% of rare diseases have no FDA-approved treatment. Globally, it is estimated that 350 million individuals are impacted by a rare disease.

Therapeutic Area User Guides provide examples and guidance on implementing CDISC standards so that data can be structured effectively and easily analyzed. CDISC Standards drive operational efficiencies within the organizations that use them, how to buy zyprexa uk without prescription expedite the regulatory review process and reduce time to market for treatments developed based on patient data.

We are grateful for the opportunity to work with NORD on this much-needed initiative. NORD’s support and partnership will allow CDISC to develop standards that facilitate more powerful research, enabling the discovery of new treatments to help patients.”

Dave Evans, President and CEO, CDISC

We have seen through NORD’s IAMRARE® registry platform the immense value of patient-powered research to serve as a catalyst for the development of rare disease treatments. We believe that by partnering with CDISC, we can help set global data standards that will lead to greater participation in research and fuel a new era of patient-centered innovation.”

Pamela Gavin, Executive Vice-President and COO, NORD

To date, CDISC has developed Therapeutic Area User Guides for over 40 disease areas.

Source:

CDISC

Posted in: Medical Condition News | Healthcare News

Tags: Catalyst, Rare Disease, Research

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