FDA Plans Pilot Project on Clinical Outcome Assessments
Posted 13 January 2016 | By
As part of the US Food and Drug Administration’s (FDA) work on patient-focused drug development, the agency is launching a pilot project where it will collate and summarize clinical outcomes on a number of different diseases in one online resource.
The clinical outcome assessment (COA) pilot project, announced Wednesday, is intended to be a starting point for companies considering how certain COAs might be used in clinical trials and early drug development.
COAs for the pilot version of the compendium have been selected from two sources:
The compendium includes the following six columns, detailing products such as anti-invectives, antivirals, ophthalmology, cardiovascular, renal, neurology, psychiatry, anesthesia, analgesia, addiction, endocrinology, pulmonary, allergy, rheumatology, dermatology, dental, gastroenterology, in born error, bone, reproductive, hematology, oncology and urologic products:
- Column 1: Disease/Condition, which includes any relevant FDA disease-specific guidance.
- Column 2: Indication and/or Claim(s) Description, which lists key elements of indication and/or claim (either labeled or qualified), though for ongoing COA qualification projects, targeted labeling or promotional claim(s) may not be yet known and may be described as to be determined.
- Column 3: Outcome of Interest, which describes an outcome of interest that was assessed (labeled) or could be assessed (in our qualification program) by COAs.
- Column 4: COA Type, which lists a labeled, qualified, or ongoing qualification project clinical outcome assessment name and/or description, and includes the clinical outcome assessment type (i.e., a patient-reported outcome, observer-reported outcome, clinician-reported outcome, or performance outcome).
- Column 5: COA Context of Use, which describes circumstances under which the outcomes of interest and the COAs that have been used (i.e., labeled) or are targeted for use (i.e., they have been qualified or are part of an ongoing qualification).
- Column 6: COA Qualification Information, which lists ongoing and completed COA qualification project information, if applicable.
FDA warns that the list is not comprehensive or intended to replace either existing disease-specific guidance or key interactions with FDA concerning drug development, such as pre-IND meetings. The COA also shouldn’t be misconstrued as the sole (or primary) determinant of a clinical benefit in a clinical trial.
In addition, some of the COAs in the compendium may be protected by proprietary rights, and in some cases, a royalty and fee may be charged by the copyright owners for their authorized use, though FDA says that does not mean the COA is endorsed by FDA.
The agency is looking for comments on the pilot COA Compendium, which it expects will help determine the compendium’s utility, and assist in developing future iterations.
Pilot: Clinical Outcome Assessment Compendium
Federal Register Notice