Ed Miseta of Clinical Leader, recently wrote an excellent article about FDA’s pilot Clinical Outcome Assessment (COA) Compendium and hit on some good points about what you need to know about it.
The FDA defines a COA as a “measure of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions. COAs can be used to determine whether or not a drug has been demonstrated to provide treatment benefit.” Understanding a disease from a patient perspective, developing a treatment that benefits the patient, and measuring the outcome in clinical trials are all parts of patient focused drug development.
Take a look at the COA Compendium table, it provides COA information for many diseases and conditions that can be useful information in future drug development. CDER is gathering public comment on the current pilot. Visit FDA to comment here. Read Miseta’s article here for more details. Contact us at Pearl IRB to help you in your patient focused drug development and clinical research.