Any disease, disorder, illness, or condition affecting fewer than 200,000 people is considered rare, according to the U.S. Food and Drug Administration. There are approximately 7,000 rare diseases affecting approximately 30 million people in the U.S., while more than 90% of rare diseases have no FDA-approved treatment.
The CDISC's 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, expedite the regulatory review process, and reduce time to market for treatments developed based on patient data.
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