The Coalition for Accelerating Standards and Therapies (CFAST) Initiative aims to accelerate clinical research and medical product development by establishing and maintaining data standards, tools, and methods for conducting research in therapeutic areas that are important to public health. It is established as a public-private partnership (PPP) involving multiple stakeholders. The Grantee funded through this announcement would be expected to accomplish activities such as, but not limited to:
Maintenance of the scientific and administrative infrastructure of the PPP to support a series of projects under the CFAST Initiative.
Coordination and management of therapeutic area standards development projects with key experts in the specific therapeutic areas, including stakeholders from industry, professional organizations, academia, and Government agencies.
Identification and engagement with key experts in the therapeutic areas, including stakeholders from industry, professional organizations, academia, and Government agencies.
Development of therapeutic area data standards, initially proposed for diabetes, QT studies, lipid lowering/altering drugs and hepatitis C. Additional or different areas can be considered as well.
Identification and implementation of continuous quality improvements with respect to the data standards development process and product(s) to facilitate timely and sustainable standards.