Since its inception, the Clinical Data Interchange Standards Consortium (CDISC) has worked to advance data standards to the highest possible quality. These standards are then used to make data more accessible and utilizable in research. In fact, the CDISC standards are required by the FDA, Japan’s PMDA, and China’s NMPA. Now, according to a news release, CDISC is partnering with the National Organization for Rare Disorders (NORD) to develop new global data standards for a variety of rare diseases.

CDISC & NORD Partnership

In the United States, a rare disease is considered any condition affecting under 200,000 citizens. Altogether, over 7,000 rare diseases exist – and a majority of them (90%) have no approved therapies. However, NORD and CDISC are working on improving this by making data more available to benefit medical research.

Currently, NORD runs the IAMRARE registry program, which NORD describes as:

an easy to use system that allows patients and organizations to inform and shape medical research and translational science for rare diseases by launching high-quality, customized registries to collect the data needed to define the natural progression of their disease – ultimately advancing product development.

Through this program, the organization has seen the benefit of patient-informed research. After all, patients are the experts in their conditions and should have a voice in the research realm. The partnership will allow for the creation of global data standards to help increase patient participation, drive patient-centered innovation, help organizations to use the data in the best way possible, and allow organizations to expedite regulatory processes and hasten treatment marketing.

Together, NORD and CDISC will create Therapeutic Area User Guides (TAUGs) for rare diseases. Currently, CDISC has created over 40 TAUGs, which:

include disease-specific metadata, examples and guidance on implementing CDISC standards for a variety of uses, including global regulatory submissions.