This session will highlight the CDISC/C-Path Partnership, which has launched therapeutic area projects to develop disease-specific standards, as well as provide an overview of therapeutic area data standards, the FDA regulatory viewpoint and roadmap for developing priority therapeutic area standards, and important viewpoints from a practicing clinician and patient advocate. Nine projects are currently underway addressing cardiovascular disease, infectious diseases, neurological disorders and kidney disease, and these have proven how clinicians, researchers, and patient advocates play a pivotal role in the often technical world of standards development. The blending of clinical knowledge, patient experiences and technical expertise into the standards development process is the key to ensuring that standards ultimately benefit the patient.

Learning Objectives:
Explain the importance of the CDISC/C-Path partnership toward developing therapeutic area standards and the benefits
Discuss FDA regulatory priorities for therapeutic area data standards in the coming years
Explain why clinicians and patients are becoming involved in standards development.