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FDA Updates COA Compendium for First Time Since 2016

Posted 21 August 2019 | By Zachary Brennan 

FDA Updates COA Compendium for First Time Since 2016

As part of the US Food and Drug Administration’s (FDA) efforts to encourage more patient-focused drug development, the agency on Wednesday released an updated Clinical Outcome Assessment (COA) Compendium as a resource on a variety of different diseases and conditions.

The compendium, which has been updated for the first time as part of an extension to a pilot COA Compendium that was launched in January 2016, can help companies understand how certain COAs have been used in clinical trials to measure a patient’s experience (such as disease-related symptoms) and to support labeling claims. It also serves to identify COAs qualified for potential use in different drug development programs.

The compendium is divided into sections based on different FDA offices, including sections on the Office of Antimicrobial Products, Office of Drug Evaluation I, II and III, and the Office of Hematology and Oncology Products.

The charts that make up the compendium are divided into five columns focused on: The disease or condition, a description of the concept that the COA assesses, the type of COA (i.e. a patient-reported outcome (PRO), observer-reported outcome, clinician-reported outcome (ClinRO) or performance outcome tool) and how the COA is listed in labeling, the circumstances under which the outcomes of interest and the COA have been used (i.e., labeled) or have been qualified and there’s a list of the brand and generic name of approved drugs, date of approval for new molecular entity (NME) labeling and the most recent approval date.

The update is an extension of the original document, FDA explains, and includes COAs from three major sources: Labeling of NME drugs and biologics approved from 2015 to June 2017, efficacy supplements pertaining to new indication and new population for first and second quarter (January to June) of 2017 and qualified measures based on CDER’s COA DDT Qualification Program.

Of the more than 30 newly added COAs, examples include the ClinRO, “Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scores,” which was used in the approval of Lucentis (ranibizumab) in April 2017; the ClinRO, “ALS Functional Rating Scale—Revised,” which was used in the approval of Radicava (edaravone injection) in May 2017; and a PRO patient diary for the migraine treatments Trokendi XR (topiramate) and Qudexy XR (topiramate), which were approved in April and March 2017, respectively.

But FDA also offers a disclaimer about the use of the COA Compendium, noting that 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.”

Clinical Outcome Assessment Compendium


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