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Clinical Outcome Assessment Compendium

 

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COA Compendium

 

 Welcome to the COA Compendium website!

The COA Compendium is part of FDA’s efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate communication and to provide clarity and transparency to drug developers and researchers by collating and summarizing clinical outcome assessment (COA) information for many different diseases and conditions into a single resource.  We suggest using the COA Compendium as a starting point when considering a COA for use in clinical trials.

The COA Compendium is a table that:

  • Describes how certain COAs have been used in clinical trials to measure the patient’s experience (such as disease-related symptoms) and to support labeling claims.
  • Identifies COAs that have been qualified for potential use in multiple drug development programs under CDER’s Drug Development Tool (DDT) Qualification Program

Disclaimer

The COA Compendium is a communication tool and it is intended to serve as a starting point in early drug development. The inclusion of a clinical outcome assessment in the COA Compendium does not equate to an endorsement by FDA and does not represent agency guidance.

Drug sponsors are strongly encouraged to seek advice from the relevant Office of New Drug (OND) review division early in drug development to discuss the selection and implementation of the clinical outcome assessment specific to their program. This is irrespective of whether the disease, condition, indication, claim, or clinical outcome assessment is included in the COA Compendium. See [All Guidances for Drugs] for a repository of guidance documents including disease-specific guidances, which may contain additional information relevant to COA selection and implementation.   

Limitations of the COA Compendium include, but are not limited to:

  • It is not a comprehensive list of COAs and is not intended to replace either existing disease-specific guidance or key interactions with FDA concerning drug development (e.g., pre-IND meetings)
  • Inclusion of a COA in the COA Compendium does not necessarily indicate that the measure is or should be the primary or sole determinant of effectiveness in a clinical trial nor is it indicative of endpoint positioning (e.g., primary or secondary)
  • The COA Compendium presents information that was available at the time it was compiled and updated; it may not include newer COAs that could be recommended for a drug development program, or more recent scientific and regulatory thinking 
  • It does not include biomarkers with the exception of biomarkers used in composite endpoints
  • It does not include the endpoint definition of labeled COAs
  • Some of the COAs listed in the COA 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

To learn more about the scope, key considerations and limitations of the COA Compendium, we strongly encourage reviewing the COA Compendium Frequently Asked Questions (FAQ).

This is the first update to the COA Compendium since the launch of the pilot in January 2016. The update is an extension of the pilot COA Compendium, and the content of the updated COA Compendium document is outlined below:

The COA Compendium content is organized based on CDER’s Office of New Drug review divisions. The table alphabetically lists conditions or diseases based on each review division’s therapeutic assignment. The shaded rows describe information about a COA DDT qualification project, whereas the unshaded rows describe information about COAs from approved drug labeling. 

The COA Compendium includes the following five columns:

COLUMNS ELEMENTS DESCRIPTION OF CONTENT
Column 1 Disease/Condition Lists disease or condition
Column 2 Concept Describes the concept that the COA assesses
Column 3 COA Tool & Type Describes the:
   • COA as listed in labeling or the qualification statement
   • COA type (e.g. a patient-reported outcome, observer-reported outcome, clinician-reported outcome, or performance outcome tool)
Column 4 COA Context of Use Describes circumstance under which the COA has been used (i.e., labeled) or has been qualified (for qualified tools under CDER’s DDT Qualification program)
Column 5 Drug Name & Approval Date Lists the brand and generic name of approved drugs, date of approval for NME labeling and the most recent approval date for efficacy supplements