CDISC and NORD to develop data standards for rare disease research

Global data standards for research in rare diseases, such as Lambert-Eaton myasthenic syndrome (LEMS), are being developed as part of a new partnership between the Clinical Data Interchange Standards Consortium (CDISC) and the National Organization for Rare disorders (NORTH).

Rare disorders in the United States are defined as those that affect fewer than 200,000 people. It is estimated that 25 to 30 million Americans live with a rare disease. Globally, approximately 350 million people are living with a rare disease.

“We are grateful for the opportunity to work with NORD on this initiative if needed,” said Dave Evans, CDISC President and CEO, in a statement. Press release. “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.”

Once completed, the data standards will be made available free of charge on the CDISC Web page, where researchers can access and use them to improve their studies. To date, the CDISC has developed guidelines for the use of similar therapeutic areas for more than 40 disease areas.

LEMS is a rare autoimmune disease that primarily affects the muscles of the lower extremities. Patients produce antibodies that mistakenly target and attack calcium channels found on nerves that control muscle movement, limiting their ability to contract affected muscles.

LEMS therapy is an active area of ​​research, as the disease currently has no cure. Several treatments exist to help manage symptoms and improve patients’ quality of life, although the options are limited.

Strict and widely accepted data standards can help make LEMS research efforts, as well as those in other rare diseases, more efficient and productive by making all relevant disease data more easily accessible, reusable and exchangeable.

The data standards developed by the CDISC were required by the United States Food and Drug Administration and the Japan Pharmaceuticals and Medical Devices Agency, and recommended by the China National Medical Products Administration. Several of the world’s leading research organizations have also adopted these standards.

“We have seen through NORD’s IAMRARE registry platform the immense value of patient-oriented research to serve as a catalyst for the development of rare disease treatments,” said Pamela Gavin, Executive Vice President and Chief Operating Officer of NORD.

“We believe that by partnering with CDISC, we can help establish global data standards that will lead to greater participation in research and fuel a new era of patient-centered innovation,” she said. added.

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