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Qualified Clinical Outcome Assessments (COA)

Qualified Clinical Outcome Assessments (COA)

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmetic Act (FD&C Act)), which was created by Section 3011 of the 21st Century Cures Act). The tables are updated on a biannual basis and provide information on the COA qualification project, qualification statement, and supporting information. Additionally, the table includes documents from requestors that were received after the passage of the 21st Century Cures Act.

FDA’s posting of information submitted to the agency by outside parties requesting qualification of a drug development tool is not an endorsement or recommendation by FDA. Information about submissions are made publicly available in accordance with section 507 of the FD&C Act. FDA makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the information about submissions. See the FDA decision letter corresponding to each submission for FDA considerations and recommendations related to each request for qualification.

To view information about submissions to the CDER COA Qualification Program for which final COA qualification determinations have not yet been made, please visit: Clinical Outcome Assessments (COA) Qualification Submissions.

Office of Drug Evaluation (ODE) I:
Division of Psychiatry Products (DPP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA
Major Depressive Disorder (MDD) DDT COA #000008: Symptoms of Major Depressive Disorder Scale (SMDDS) Overall symptoms of MDD Adults (>18 years) with a clinical diagnosis of MDD and:
  • treated in an ambulatory setting
  • experienced a major depressive episode within the last 6 months
  • a HAM-D score > 18 meets the DSM-IV or DSM-V criteria for MDD

Office of Drug Evaluation (ODE) II:
Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type
Acute Bacterial Exacerbation of Chronic Bronchitis in patients with Chronic Obstructive Pulmonary Disease (ABECB-COPD) DDT COA #000003: Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Symptoms of ABECB-COPD Outpatients with ABECB-COPD who meet the clinical trial entry criteria as described in the FDA Guidance: Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.    PRO

DDT COA #000006: Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)

Asthma symptoms Adolescent (12 -17 years) and adult patients PRO
Chronic Obstructive Pulmonary Disease (COPD) DDT COA #000017: Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Respiratory symptoms of stable COPD Adult outpatients with stable COPD PRO

Office of Hematology and Oncology Products (OHOP):
Division of Oncology Products 2 (DOP 2)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type
Non-Small Cell Lung Cancer (NSCLC) DDT COA #000009: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Symptom severity (cough, pain, dyspnea, fatigue, and appetite) Adult patients (> 18 years) with Stage IIIB or IV NSCLC that are:
  • Treatment naïve (i.e., treatment naïve to current chemotherapy and not having received chemotherapy for the past 6 months from study enrollment)
  • Treated (i.e., received chemotherapy in the last 6 months and recovered from any prior treatment related toxicities/adverse events to CTCAE v4.03 grade 1 or better)

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