Funding Opportunity RFA-DA-20-015 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement is to support the development of Clinical Outcome Assessments (COAs) for Substance Use Disorders (SUDs) aiming to be qualified by the Food and Drug Administration (FDA) as Drug Development Tools (DDTs).The FDA qualification of a COA is based on a review of the evidence to support the conclusion that the COA is a “well-defined and reliable assessment of a targeted concept(s) in a specified context of use in adequate and well-controlled investigations”. Once qualified as a DDT, the COA will become a publicly available instrument and can be deployed within a specified context of use (COU) as a sensitive, reliable and validated instrument. COA can be a patient-reported outcome (PRO), a clinician-reported outcome (ClinRO), an observer-reported outcome (ObsRO) or a performance outcome (PerfO). Applications may focus on the creation and development of a new COA, or on modification/optimization of an existing COA. The final goal is to have FDA-qualified COA(s) measure(s) that would be acceptable to regulatory authorities when used in SUDs clinical trials. It is expected that such FDA-qualified COAs will have a potential to catalyze the regulatory approval path for new treatments.
National Institutes of Health (NIH)
As of 2013, the IRP had 1,200 principal investigators and more than 4,000 postdoctoral fellows in basic, translational, and clinical research, being the largest biomedical research institution in the world, while, as of 2003, the extramural arm provided 28% of biomedical research funding spent annually in the U.S., or about US$26.4 billion.
The NIH comprises 27 separate institutes and centers of different biomedical disciplines and is responsible for many scientific accomplishments, including the discovery of fluoride to prevent tooth decay, the use of lithium to manage bipolar disorder, and the creation of vaccines against hepatitis, Haemophilus influenzae (HIB), and human papillomavirus (HPV).