Development of Clinical Outcome Assessments for Clinical Trials in Substance Use Disorders as FDA-qualified Drug Development Tools (U01 Clinical Trial Optional)

Funding Agency:
National Institutes of Health

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.



  • Letter of Intent Due Date(s): 30 days prior to the application due date
  • Application Due Date(s): October 23, 2019

​RFA-DA-20-015 Expiration Date October 24, 2019

Agency Website



Amount Description

Application budgets are expected not to exceed $500,000 per year per each award in direct costs.

 The maximum project period is 3 years 

    Funding Type





    Medical - Clinical Science
    Medical - Translational

    External Deadline

    October 23, 2019