CDISC, NORD to Develop Data Standards for Rare Disease Trials
Two nonprofits are partnering to develop global data standards for rare disease trials that will give sponsors and sites guidance on collecting and analyzing data on such things as a patient’s medical history, the dosing of investigational drugs and, in cancer trials, the types of tumors being targeted.
The Clinical Data Interchange Standards Consortium (CDISC) is teaming up with the National Organization for Rare Disorders (NORD) and will release the standards in a therapeutic area user guide, adding it to CDISC’s library of data standards for more than 40 other therapeutic areas.
CDISC said it anticipates that a draft standard will be available for public review by year’s end, and the final standard published in the first quarter of next year.
Last month, CDISC published a supplement that expanded its existing trial data standards to help sites reduce duplication when reporting on adverse events to sponsors and regulators (CenterWatch Weekly, April 26, 2021).