Drugs

Clinical Outcome Assessments (COA) Qualification Submission

The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been made. The tables include legacy projects (those submitted prior to enactment 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). These tables only include documents from requestors that were received after the passage of the 21st Century Cures Act. The tables are updated on a biannual basis and provide information on the COA qualification project, including FDA’s decision to accept or not accept the submission, and FDA’s recommendations on further COA development.

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 of the tool’s use. Information about submissions is made publicly available in accordance with section 507 of the FD&C Act. The FDA makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the information in submissions. See the FDA decision letter corresponding to each submission for FDA considerations and recommendations related to each request for qualification.

The COA Qualification Submissions tables were last updated November 6, 2018 and include submissions received through March 30, 2018. To view qualified COAs, please visit: Qualified Clinical Outcome Assessments (COAs).

Office of Drug Evaluation (ODE) I:
Division of Cardiovascular and Renal Products (DCaRP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Heart Failure (HF) DDT COA #000084: Kansas City Cardiomyopathy Questionnaire (KCCQ) HF symptoms and their impact on physical limitations Patients with HF PRO In legacy process*
Varicose Veins DDT COA #000056: Varicose Vein Symptom Questionnaire (VVSymQ) Varicose vein symptoms Patients with superficial venous incompetence PRO In legacy process*

*Under review prior to the passage of the 21st Century Cures Act

Division of Neurology Products (DNP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Alzheimer’s Disease DDT COA #000004: PerfO to assess instrumental activities of daily living (IADLs) Day to day functioning Adults (>45 years) with mild cognitive impairment due to Alzheimer’s Disease PerfO In transition to 507 process 
Duchenne Muscular Dystrophy (DMD) DDT COA #000103: ActiMyo® Daily motor activity Children, adolescent, and adult patients (> 5 years old) with DMD Other Letter of Intent- Accepted
Dystrophinopathy DDT COA #000032: Abilities Captured through Interactive Video Evaluation (ACTIVE)-seated Functional reaching volume (FRV) intended to encompass upper extremity and trunk movement Children (>4-12 years) and adolescents (12-17 years) and adults with Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD) PerfO In transition to 507 process 
Facioscapulohumeral muscular dystrophy (FSHD) DDT COA #000090: Facioscapulohumeral Composite Functional Outcome Measure (FSHD-COM) Physical functioning Patients with FSHD PerfO Letter of Intent- Not Accepted
Multiple Sclerosis (MS) DDT COA #000053: Symbol Digit Modalities Test (SDMT) Processing speed Adults with a diagnosis of MS and a relapsing-remitting (RRMS), secondary progressive (SPMS), or primary progressive (PPMS) clinical course PerfO In transition to 507 process 
Multiple Sclerosis (MS) DDT COA #000069: PROMIS® Physical Functioning Item Bank Physical functioning Patients with MS PRO In transition to 507 process 

Office of Drug Evaluation (ODE) II:
Division of Anesthesia, Analgesia, and Addiction Products (DAAAP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Musculoskeletal pain DDT COA #000102: Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT) Physical activity Non-cognitively impaired adults with a diagnosis of osteoarthritis of the knee Other Letter of Intent- Accepted
Pain DDT COA #000073: QUALIfied for Therapeutic Evaluations of Pain (QUALITE-Pain) Pain intensity Non-cognitively impaired adults with acute and chronic pain PRO In transition to 507 process 

Division of Metabolism and Endocrinology Products (DMEP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Hip fracture DDT COA #000037: Usual Gait Speed (UGS) and the Short Physical Performance Battery (SPPB) Lower-extremity functional decline Adult patients (>65 years) who have diminished muscle mass, muscle strength and decreased function as a result of hip fracture PerfO In transition to 507 process 
Sarcopenia DDT COA #000085: PROMIS®  Physical Functioning Item Bank Physical functioning Patients with sarcopenia PRO In transition to 507 process 

Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Asthma DDT COA #000006: Asthma Daily Symptom Diary (ADSD) Asthma symptoms Adolescent (12 -17 years) and adult patients with mild to severe persistent asthma PRO In transition to 507 process 
Asthma DDT COA #000099: Child Asthma Diary (CAD) Symptom severity Children (4-11 years) with a clinical diagnosis of mild to severe persistent asthma requiring a daily long-term control medication PRO/ObsRO In transition to 507 process 
Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
Systemic Exertion Intolerance Disease (SEID)
DDT COA #000080: PROMIS® Fatigue Item Bank Fatigue Patients with CFS, ME, or SEID PRO In transition to 507 process 
Chronic Obstructive Pulmonary Disease (COPD) DDT COA #000072: Constant Work Rate Exercise Exercise endurance COPD patients with moderate to very severe lung function impairment:
  • Patients diagnosed with COPD
  • Post-bronchodilator FEV1/FVC <70%
  • Post-bronchodilator FEV1 <80% predicted normal
  • Male or female patients, at least 40 years of age
Current or ex-smokers with a smoking history of more than 10 pack-years.
PerfO In transition to 507 process 
Idiopathic pulmonary fibrosis (IPF) DDT COA #000027: A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF) Symptom experience, daily functioning and other health-related quality of life impacts Adult patients (>18 years) with IPF PRO In transition to 507 process 
Rheumatoid Arthritis (RA) DDT COA #000015: PROMIS® Short Form Fatigue 10a in Rheumatoid Arthritis Fatigue Adult patients (>18 years) with a definite diagnosis of RA based on a score of ≥ 6 on the American College of Rheumatology/European League Against Rheumatism 2010 Rheumatoid Arthritis Classification Criteria PRO In transition to 507 process 

Office of Drug Evaluation (ODE) III:
Division of Gastroenterology and Inborn Error Products (DGIEP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Crohn’s disease (CD) DDT COA #000034: Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS) Signs and symptoms of CD Adult patients (>18 years) with moderate to severe clinically active CD treated in the outpatient setting PRO In transition to 507 process 
Crohn’s disease (CD) DDT COA #000076: TUMMY-CD Signs and symptoms of CD Pediatric patients with CD PRO In transition to 507 process 
Crohn’s disease (CD) DDT COA #000092: PROMIS® Pediatric Crohn’s Disease Short Form - Fatigue 10 Fatigue (frequency, duration and intensity) Children (8-17 years) with CD PRO Letter of Intent- Accepted
Eosinophilic Esophagitis (EoE) DDT COA #000024: Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module (PEESS™ v2.0) EoE Symptoms Children (2-12 years) and adolescents (12-18 years) with EoE ObsRO In transition to 507 process 
Functional dyspepsia (FD) DDT COA #000013: Functional Dyspepsia Symptom Diary (FDSD) FD symptom severity Adult patients that have met Rome III diagnostic criteria for FD PRO In transition to 507 process 
Gastroparesis DDT COA #000020: The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Gastroparesis symptoms Adult patients (>18 years) with idiopathic or diabetic gastroparesis PRO In transition to 507 process 
Irritable Bowel Syndrome (IBS) DDT COA #000005: Diary of Irritable Bowel Syndrome Symptoms- Constipation/ Diarrhea/ Mixed (DIBSS-C/D/M) IBS signs and symptoms Adult patients with IBS-C, IBS-D, or IBS-M PRO In transition to 507 process 
Polycystic Liver Disease (PLD) DDT COA #000075: Polycystic Liver Disease Questionnaire (PLD-Q) PLD symptoms Adult patients with Gigot stage II or III PLD PRO In transition to 507 process 
Ulcerative colitis (UC) DDT COA #000040: Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS) Signs and symptoms of UC Adult patients (≥18 years of age) with moderate to severe UC PRO In transition to 507 process 
Ulcerative colitis (UC) DDT COA #000041: TUMMY- UC UC signs and symptoms severity Children and adolescents (2-18 years) with UC PRO/ObsRO In transition to 507 process 

Division of Dermatology and Dental Products (DDDP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Alopecia areata (AA) DDT COA #000101: Patient-Reported Symptoms and Impacts of Alopecia Areata Concepts related to hair loss and regrowth deemed important by patients with AA Adult patients (> 18 years) with AA with at least > 25% hair loss on scalp and current episode of hair loss lasting at least 6 months PRO Letter of Intent- Accepted

Office of Antimicrobial Products (OAP):
Division of Anti-Infective Products (DAIP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Acute Bacterial Skin and Skin Structure Infection DDT COA #000019: Skin Infection Patient-Reported Outcome Measure (SKINFECT-PRO) ABSSSI symptoms Adult patients (> 18 years) with ABSSSI PRO In transition to 507 process 
Community-Acquired Bacterial Pneumonia (CABP) DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) specific to CABP and HABP CABP symptoms  Adult patients (> 18 years) with CABP PRO In transition to 507 process 
Cystic Fibrosis (CF) DDT COA #000007: The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) CF symptom severity Adolescents (≥12 years) and adults with a chronic respiratory infection in stable patients and patients with an acute exacerbation PRO In legacy process*
Hospital-acquired Bacterial Pneumonia (HABP) DDT COA #000071: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) specific to CABP and HABP HABP symptoms Adult patients (> 18 years) with HABP PRO In transition to 507 process 

*Under review prior to the passage of the 21st Century Cures Act

Office of Hematology and Oncology Products (OHOP) 

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Cancer DDT COA #000079: PROMIS® Physical Function in Oncology Physical functioning Adult patients (> 18 years) with solid tumors or hematologic malignancies with a performance status range 0-3 and receiving active anti-cancer therapy PRO In transition to 507 process 

Division of Hematology Products (DHP)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Sickle Cell Disease (SCD) DDT COA #000057: Sickle Cell Pain Diary Pain intensity and pain interference Pediatric patients with SCD PRO In transition to 507 process 

Division of Oncology Products 2 (DOP 2)

Disease/Condition DDT COA Number and Instrument Name Concept of Interest Context of Use COA Type Qualification
Stage
Plexiform neurofibroma (PN) DDT COA #000061: Plexiform Neurofibroma Impact in Children & Adults Tumor-related pain intensity, pain interference, and physical functioning Children(>5 years) and adults with neurofibromatosis type 1 (NF1) and PN PRO In transition to 507 process 

 

Page Last Updated: 12/12/2018
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