FDA Requests Input on Clinical Outcome Assessments Compendium
On April 1, 2015, FDA held a public workshop entitled, “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.” During the meeting, the Agency provided “updates on accomplishments, challenges, and ongoing efforts in the use of clinical outcome assessments (COAs).”
What is the COA Compendium?
As a part of its efforts to foster patient-focused drug development the FDA developed the pilot COA Compendium, which is “a table that:
- Describes how certain clinical outcome assessments have been used in clinical trials to measure the patient’s experience (such as disease-related symptoms) and to support labeling claims.
- Identifies clinical outcome assessments that have been qualified for potential use in multiple drug development programs under the COA type of the Drug Development Tool (DDT) Qualification Program of the Center for Drug Evaluation and Research (CDER).
- Recognizes ongoing qualification projects to encourage community collaboration in the development of clinical outcome assessments for unmet measurement needs.”
The FDA developed the COA Compendium with the intention of facilitating communication and providing “clarity and transparency to drug developers and the research community by collating and summarizing COA information for many different diseases and conditions into a single resource. It can be used as a starting point when considering how certain clinical outcome assessments might be utilized in clinical trials and will likely be most informative in early drug development.”
Establishment of a Docket
On January 13, FDA announced the establishment of a docket, which will be used “to receive suggestions, recommendations, and comments from interested parties,” regarding the first version of its pilot COA Compendium.
The FDA made this announcement in the Federal Register, and stated that the comments received during the COA Compendium’s pilot phase “will help FDA determine its utility, and may assist FDA in developing future iterations of the COA Compendium and identifying best methods for conveying COA Compendium information on FDA’s web site.”
Comments are being accepted until March 14, 2016, and can be made via paper or electronic submission (here).