Clinical Outcome Assessments (COA) Qualification Program Submissions
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.
To view qualified COAs, please visit: Qualified Clinical Outcome Assessments (COAs).
Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of Cardiology and Nephrology (DCN)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Chronic Heart Failure (CHF) | DDT COA #000112: Chronic Heart Failure- Symptom Scale (CHF-SS) | CHF symptoms | Patients with CHF | PRO | Letter of Intent- Accepted |
| Chronic Heart Failure (CHF) | DDT COA #000113: Chronic Heart Failure- Impact Scale (CHF-IS) | CHF symptom impacts | Patients with CHF | PRO | Letter of Intent- Accepted |
| Chronic Heart Failure (CHF) | DDT COA #000114: Chronic Heart Failure- Activity Monitor-Based Endpoint Measure | Daily physical activity | Patients with CHF | DHT- Passive Monitoring COA | Letter of Intent- Accepted |
| Chronic Kidney Disease (CKD) | DDT COA #000095: PROMIS® Pediatric Chronic Kidney Disease Short Form- Fatigue | Fatigue | Children (8-17 years) with CKD | PRO | Letter of Intent- Accepted |
| Chronic Kidney Disease (CKD) | DDT COA #000119: PROMIS® Pediatric Chronic Kidney Disease Short Form- Sleep Disturbance | Sleep Disturbance | Children (8-17 years) with CKD | PRO | Letter of Intent- Accepted |
| 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 General Endocrinology (DGE)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Hip fracture | DDT COA #000037: 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 | Letter of Intent- Accepted |
| Sarcopenia | DDT COA #000085: PROMIS® Physical Functioning in Sarcopenia | Physical functioning | Patients with sarcopenia | PRO | Letter of Intent- Accepted |
| Sarcopenia | DDT COA #000105: Actibelt® in Sarcopenia | Change in real-world walking speed | Patients with sarcopenia in recovery after surgical treatment of hip fracture | DHT- Passive Monitoring COA | Letter of Intent- Accepted |
Division of Nonmalignant Hematology (DNH)
| 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 | Letter of Intent- Accepted |
Division of Diabetes, Lipid Disorders, and Obesity (DDLO)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Obesity | DDT COA #000036: Impact of Weight on Quality of Life- Lite (IWQOL-Lite) Clinical Trials Version | Weight-related quality of life concepts |
| PRO | Letter of Intent- Accepted |
Office of Neuroscience (ON)
Division of Neurology I (DNI)
| 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 | Letter of Intent- Accepted |
| Duchenne Muscular Dystrophy (DMD) | DDT COA #000103: ActiMyo® | Daily motor activity | Children, adolescent, and adult patients (> 5 years old) with DMD | DHT- Passive Monitoring COA | Letter of Intent- Accepted |
| Duchenne Muscular Dystrophy (DMD) | DDT COA #000104: Duchenne Video Assessment | Quality of movement | Ambulatory patients > 4 years old with DMD | ClinRO | 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 | Letter of Intent- Accepted |
| 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 |
| Huntington’s Disease (HD) | DDT COA #000129: Advanced Gait Analysis | Progressive gait abnormality | Ambulatory adults with pathogenic genetic mutation and CAG expansion indicative of HD | DHT- Passive Monitoring COA | Letter of Intent- Not Accepted |
| Parkinson’s Disease (PD) | DDT COA #000142: Virtual Motor Exam for Parkinson’s Disease, Part III Estimator (VME Part III) | Motor symptom severity | Adults diagnosed with Parkinson’s Disease | DHT- Passive Monitoring COA | Letter of Intent- Not Accepted |
Division of Neurology II (DN II)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| 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 | Qualification Plan- Accepted |
| Multiple Sclerosis (MS) | DDT COA #000069: Fatigue PRO in Multiple Sclerosis | Physical functioning | Patients with MS | PRO | Letter of Intent- Accepted |
| Multiple Sclerosis (MS) | DDT COA #000106: Actibelt® in MS | Change in real-world walking speed | Patients with MS | DHT- Passive Monitoring COA | Letter of Intent- Accepted |
| Multiple Sclerosis (MS) | DDT COA #000123: Physical Function PRO in Multiple Sclerosis | Physical functioning | Patients with MS | PRO | Letter of Intent- Accepted |
Division of Psychiatry (DP)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Major Depressive Disorder (MDD) | DDT COA #000108: Symptoms of Major Depressive Disorder Diary (SMDDD) | Depression symptom severity | Adults with MDD with a 24-hour recall period | PRO | Letter of Intent- Accepted |
| Major Depressive Disorder (MDD) | DDT COA #000109: Symptoms of Major Depressive Disorder Momentary Assessment (SMDDMA) | Depression symptom severity | Adults with MDD “at this moment” | PRO | Letter of Intent- Accepted |
| Major Depressive Disorder (MDD) | DDT COA #000122: Telemedicine-based Administration of the Montgomery-Asberg Depression Rating Scale (MADRS) | Signs and symptoms of depression | Adults (18-65 years) with MDD treated in an ambulatory setting and who have experienced a major depressive episode within the previous 6 months | ClinRO | Letter of Intent- Not Accepted |
| Schizophrenia | DDT COA #000107: Virtual Reality Functional Capacity Assessment Tool (VRFCAT) | Functional capacity | Patients with schizophrenia | PerfO | Letter of Intent- Accepted |
| Schizophrenia | DDT COA #000115: EPICOG-SCH | Cognitive impairment | Patients with schizophrenia | PerfO | Letter of Intent- Accepted |
Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Alcohol use disorder (AUD) | DDT COA #000110: WHO Risk Drinking Levels of Alcohol Consumption | WHO 2-level risk drinking reduction | Patients diagnosed with an AUD | PRO | Letter of Intent- Accepted |
| 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 | DHT- Passive Monitoring COA | Letter of Intent- Accepted |
| Opioid Use Disorder (OUD) | DDT COA #000138: Opioid Craving PRO | Changes in opioid craving | Patients with mild to severe OUD | PRO | 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 | Letter of Intent- Accepted |
| Recovery from surgery and anesthesia | DDT COA #2019-01: PostopQRS | Recovery process | Patients undergoing all forms of surgery and anesthesia | PRO, PerfO, and ClinRO | Letter of Intent- Not Accepted |
Office of Immunology and Inflammation (OII)
Division of Rheumatology and Transplant Medicine (DRTM)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Chronic Fatigue Syndrome (CFS) Myalgic Encephalomyelitis (ME) Systemic Exertion Intolerance Disease (SEID) | DDT COA #000080: PROMIS® Fatigue for ME/CFS/SEID | Fatigue | Patients with CFS, ME, or SEID | PRO | Letter of Intent- Accepted |
| 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 | Qualification Plan- Accepted |
| Systemic Lupus Erythematosus (SLE) | DDT COA #000135: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Systemic Lupus Erythematosus (SLE) | Presence and severity of signs of cutaneous manifestations | Patients with SLE | ClinRO | Letter of Intent-Accepted |
Division of Pulmonary, Allergy, and Critical Care (DPACC)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| 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 | Letter of Intent- Accepted |
| Chronic Obstructive Pulmonary Disease (COPD) | DDT COA #000072: Constant Work Rate Exercise | Exercise endurance | COPD patients with moderate to very severe lung function impairment:
Current or ex-smokers with a smoking history of more than 10 pack-years. | PerfO | Qualification Plan- Not Accepted |
| Chronic Obstructive Pulmonary Disease (COPD) | DDT COA #000125: Endurance Shuttle Walking Test (ESWT) | Walking endurance | COPD patients | PerfO | Qualification Plan- Not Accepted |
| 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 | Letter of Intent- Accepted |
Division of Gastroenterology (DG)
| 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 | Letter of Intent- Accepted |
| Crohn’s disease (CD) | DDT COA #000049: Pediatric Inflammatory Crohn’s MRE Index (PICMI) | Disease activity | Children (5-17 years) with CD | ClinRO | Letter of Intent- Accepted |
| Crohn’s disease (CD) | DDT COA #000076: TUMMY-CD | Signs and symptoms of CD | Pediatric patients with CD | PRO | Letter of Intent- Accepted |
| 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 |
| Crohn’s Disease (CD) | DDT COA #000093: PROMIS® Pediatric Crohn’s Disease Short Form – Pain Interference | Pain interference | Children (8-17 years) with CD | PRO | Letter of Intent- Not 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 | Letter of Intent- Accepted |
| 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 | Letter of Intent- Accepted |
| 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 | Letter of Intent- Accepted |
| Irritable Bowel Syndrome | DDT COA #000148: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D) | Symptom Severity | Adults who meet Rome diagnostic criteria (Rome III or IV) and have active symptoms | PRO | Letter of Intent- Accepted |
| Irritable Bowel Syndrome | DDT COA #000151: Diary for Irritable Bowel Syndrome Symptoms- Mixed (DIBSS-M) | Symptom Severity | Adults who meet Rome diagnostic criteria (Rome III or IV) for IBS-M and have active symptoms | PRO | Letter of Intent- Accepted |
| 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 legacy process* |
| Ulcerative colitis (UC) | DDT COA #000041: TUMMY- UC | UC signs and symptoms severity | Children and adolescents (2-18 years) with UC | PRO/ObsRO | Withdrawn |
Division of Hepatology and Nutrition (DHN)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| 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 | Letter of Intent- Accepted |
Division of Dermatology and Dentistry (DDD)
| 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 |
| Atopic dermatitis | DDT COA #000120: Scratch Sensor | Itch intensity and persistence | Patients > 2 years with atopic dermatitis | DHT- Passive Monitoring COA | Letter of Intent- Accepted |
| Cutaneous Lupus Erythematosus (CLE) | DDT COA #000130: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Cutaneous Lupus Erythematosus (CLE) | Presence and severity of signs of CLE | Patients with CLE | ClinRO | Letter of Intent- Accepted |
| Hidradenitis suppurativa (HS) | DDT COA #000111: Hidradenitis Suppurativa Quality of Life (HiSQOL) | Symptom severity, limitations in performance of activities, and psychosocial effects | Adult patients with HS | PRO | Letter of Intent- Accepted |
| Hidradenitis suppurativa (HS) | DDT COA #000118: Hidradenitis Suppurativa Area and Severity Index (HASI) | Disease severity and extent of active (inflamed) HS | Adult patients with HS | ClinRO | Letter of Intent- Accepted |
| Itch | DDT COA #000116: PROMIS Itch Questionnaire – Children Impact (PIQ-C-Impact) | Itch impacts on children’s daily living | PRO to be completed by children between ages 8-17 years ObsRO to be completed by parents of children ages 5-17 years | PRO and ObsRO | Letter of Intent – Not Accepted |
| Itch | DDT COA #000140: PROMIS Itch Questionnaire – Children Symptom (PIQ-C-Symptom) | Itch symptoms in children | PRO to be completed by children between ages 8-17 years ObsRO to be completed by parents of children ages 5-17 years | PRO and ObsRO | Letter of Intent – Not Accepted |
Office of Infectious Diseases (OID):
Division of Anti-Infectives (DAI)
| 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 | Letter of Intent- Accepted |
| Acute otitis media (AOM) | DDT COA #000083: Acute Otitis Media Severity of Symptoms Scale (AOM-SOS) | AOM symptoms | Children with AOM | ObsRO | Letter of Intent- Accepted |
| Community-Acquired Bacterial Pneumonia (CABP) | DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of CABP symptoms | CABP symptoms | Adult patients (> 18 years) with CABP | PRO | Letter of Intent- Accepted |
| 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) for the measurement of HABP symptoms | HABP symptoms | Adult patients (> 18 years) with HABP | PRO | Letter of Intent- Accepted |
| Non-Cystic Fibrosis Bronchiectasis (NCFBE) | DDT COA #000128: Symptom Assessment for Bronchiectasis (SABRE) | Disease related symptoms | Adult patients (>21 years) with NCFBE with or without non-tuberculous mycobacterial (NTM) infection | PRO | Letter of Intent- Accepted |
*Under review prior to the passage of the 21st Century Cures Act
Office of Oncologic Diseases (OOD)
| 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 | Qualification Plan- Accepted |
| Cancer | DDT COA #000121: EORTC Quality of Life Core Questionnaire Physical Functioning (EORTC QLQ-C30) | Physical functioning | Adult patients (> 18 years) with cancer- all tumor types, locations, and stage of disease | PRO | Letter of Intent- Not Accepted |
Division of Oncology 1 (DO1)
| 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 | Letter of Intent- Accepted |
| Renal cell carcinoma (RCC) | DDT COA #000117: Network/Function Assessment of Cancer Therapy- Disease Related Symptom Scale (NFKSI-DRS) | Disease-related symptoms of RCC | Adult patients (>18 years) with advanced or metastatic (AJCC stage IV) RCC | PRO | Letter of Intent- Accepted |
Division of Oncology 2 (DO2)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Small cell lung cancer (SCLC) | DDT COA #000133: Small Cell Lung Cancer PRO | SCLC symptom severity | Adult patients adults (>18 years) with clinician-confirmed diagnosis of limited or extensive stage SCLC with Eastern Cooperative Oncology Group performance status of 0 to 2, regardless of the lines of therapy being administered | PRO | Letter of Intent- Accepted |
Office of Specialty Medicine (OSM):
Division of Ophthalmology (DO)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Retinitis Pigmentosa (RP) | DDT COA #000126: Functional Vision Questionnaire (FVQ) PRO | Visual function and functional vision | Adolescents (12-17 years) and adults (>18 years) with a clinical and genetic confirmed diagnosis of RP | PRO | Letter of Intent- Accepted |
| Retinitis Pigmentosa (RP) | DDT COA #000127: Functional Vision Questionnaire (FVQ) ObsRO | Visual function and functional vision | Pediatric (3-11 years) patients with a clinical and genetic confirmed diagnosis of RP | ObsRO | Letter of Intent- Accepted |
Resources
- CDER & CBER’s DDT Qualification Project Search database
- CDER COA Qualification Program
- CDER COA Qualification Program FAQs
- CDER COA Qualification Program Resources
- Qualified COAs
- DCOA Homepage
- Drug Development Tools
*Under review prior to the passage of the 21st Century Cures Act