Drugs

Clinical Outcome Assessment Qualification Program Submissions

Qualification process facilitates a collaborative setting where the Clinical Outcome Assessment Drug Development Tool (COA DDT) Qualification Program works with the submitter(s) in guiding COA development. Multiple interested parties often work together in working groups or consortia, to develop a COA for qualification. This approach allows for shared resources, thereby reducing committed resources for individual collaborators. In turn, this may encourage interested parties to join a DDT development effort despite limited resources.

The FDA/CDER COA DDT Qualification Program invites submitters who have a COA qualification project accepted into the Program to voluntarily provide general information about their project and contact information to be posted on the FDA’s public web site. The intent is to facilitate collaborative COA development efforts.

The table below lists submissions that are currently in the qualification process. Submissions listed here are only for those which submitters have agreed to make public.

For more information about the COA Qualification Program, you may contact:

CDER-COA DDT Qualification Program
Email: COADDTQualification@fda.hhs.gov
Phone: 301-796-0900
 

Qualified Clinical Outcome Assessments 

SubmitterName of InstrumentType of COAIssuance Date with Link to Qualification StatementLink to Supporting Information
Evidera

Contact:
Nancy Leidy
Exacerbations of Chronic Pulmonary Disease Tool (EXACT)* (PDF - 80KB) PRO01/09/2014Study Endpoints and Labeling Development (SEALD) Review (PDF - 1MB)
Clinical Review (PDF - 131KB)
Biostatistics Review (PDF - 323KB)
Evidera

Contact:
Nancy Leidy
Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD)* (PDF - 50KB)PRO03/10/2016Clinical Outcome Assessments Staff Review (PDF – 2MB)
Patient-Reported Outcome Consortium
Critical Path Institute
See Qualification Statement for contact information  
Symptoms of Major Depressive Disorder Scale (SMDDS)  (PDF - 116KB)PRO 11/27/2017 Supporting information will be posted once available. 
Patient-Reported Outcome Consortium Critical Path Institute
See Qualification Statement for Contact Information
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) (PDF - 33KB)PRO04/04/2018Supporting information will be posted once available

Clinical Outcome Assessment Qualification Submissions

SubmitterName of InstrumentConcept of interest in context of useType of COADate accepted into qualification programQualification stage**
Critical Path Institute: PRO Consortium, Asthma Working Group
Contact:
Stephen Coons
Asthma Daily Symptom Diary (ADSD)Symptoms of asthma in adolescents (12 to 17 years) and adults (≥18 years) with mild to severe persistent asthmaPRO11/17/2010Review
Critical Path Institute: PRO Consortium, Non-Small Cell Lung Cancer Working Group
Contact:
Stephen Coons
Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)Symptoms of advanced NSCLC in adult (≥18 years) with stage IIIB/IV NSCLCPRO07/27/2011Review
Evidera & The Cystic Fibrosis Foundation
Contact:
Katharine Gries
Bruce Marshall
The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)Severity of symptoms of cystic fibrosis in adults and adolescents (≥12 years) with a chronic respiratory infection in stable patients and patients with an acute exacerbationPRO10/30/2013Review
BTG International, Inc
Contact:
Simon Leppard
Varicose Vein Symptom Questionnaire (VVSymQ)Varicose vein symptoms in patients with superficial venous incompetencePRO05/13/2014Review
National Institute of Allergy and Infectious Diseases, Leidos Biomedical Research, Department of Defense, and Evidera
Contact:
Nancy Leidy
John Powers
Flu-PROPresence and severity of patient-reported influenza symptoms in adult and pediatric patients with documented influenzaPRO03/30/2010Consultation & Advice
Critical Path Institute: PRO Consortium, Irritable Bowel Syndrome (IBS) Working Group
Contact:
Stephen Coons
Currently unnamed
(Three PRO measures to assess the signs and symptoms of the three main subtypes of IBS: IBS-C, IBS-D, and IBS-M)
Signs and symptoms of IBS in adults (≥18 years) with IBS-C, IBS-D, or IBS-MPRO04/29/2010Consultation & Advice
American Neurogastroenterology and Motility Society
Contact:
Henry Parkman
Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI)Gastroparesis symptoms in outpatients who are 18 years or older who have been diagnosed with idiopathic or diabetic gastroparesisPRO12/27/2011Consultation & Advice
Contact:
MarcRothenberg
Pediatric Eosinophilic Esophagitis (EoE) Score (PEES™ v2.0)Esophageal symptoms in children and teens ages 8-18 yearsPRO1/03/2012Consultation & Advice
National Jewish Health
Contact:
Jeff Swigris
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  in idiopathic pulmonary fibrosisPRO01/25/2012Consultation & Advice
Critical Path Institute: PRO Consortium, Functional Dyspepsia Working Group
Contact:
Stephen Coons
Functional Dyspepsia Symptom Diary (FDSD)Symptoms of FD in adults (≥18 years) that have met Rome III diagnostic criteria for FDPRO02/29/2012Consultation & Advice
Dan Turner
Anne Griffiths
Modified Pediatric Ulcerative Colitis Activity Index (PUCAI) / TUMMY Scale*Signs and symptoms of pediatric UC in children 4-18 years of age, of all disease activity states.PRO02/07/2013Consultation & Advice
Foundation for the National Institutes of Health (FNIH)
Contact:
Steve Hoffmann
Acute Bacterial Skin and Skin Structure Infection (ABSSSI) PRO Symptoms of ABSSSI, and their impact on how patients; functioning, in adult patients with a diagnosis of ABSSSIPRO03/01/2013Consultation & Advice
IBD PRO Consortium
Contact:
Gale Harding

Ulcerative Colitis Patient Reported Outcomes Signs and Symptoms (UC-PRO/SS)

The UC-PRO/SS will be used to assess the effects of treatment on patient-reported UC signs and symptoms in clinical trials among patients with moderate to severe UC.

PRO3/14/13Consultation & Advice
IBD PRO Consortium
Contact:
Gale Harding

Crohn’s Disease Patient Reported Outcomes Signs and Symptoms (CD-PRO/SS)

The CD-PRO/SS will be used to assess the effects of treatment on patient-reported CD signs and symptoms in clinical trials among patients with moderate to severe CD.

PRO04/01/2013Consultation & Advice
Quality of Life Consulting & Duke University Medical Center
Contact:
Ronette Kolotkin
IWQOL-Lite Clinical Trials VersionImprovements in specific aspects of HRQOL following weight loss in overweight and obese adult patientsPRO04/19/2013Consultation & Advice
Foundation for the National Institutes of Health (FNIH)
Contact:
Steve Hoffmann
Community Acquired Bacterial Pneumonia (CABP) PRO Symptoms of CABP, both respiratory and non-respiratory, and their impact on patients’ functioning, in adult patients 18 years of age and older with a diagnosis of CABPPRO05/07/2013Consultation & Advice
The Research Institute at Nationwide Children’s Hospital
Contact:
Linda Lowes
Abilities Captured through Interactive Video Evaluation (ACTIVE)-seatedFunctional reaching volume (FRV) intended to encompass upper extremity and trunk movement for use in children (4 years of age and older) and adults with dystrophinopathy, both Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD)PerfO05/30/2013Consultation & Advice
Critical Path Institute
Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
Contact:
Lynn Hudson
PerfO to assess cognition in MS“Multiple sclerosis (MS) disability”, or simply “disability”, characterized as neurological or neuropsychological deficits that result in limitation in activities, participation, or roles, caused by MS, that are understood to be important by adults living with relapsing-remitting or progressive forms of MS. PerfO12/23/2013Consultation & Advice
Aging in Motion Coalition of the Alliance for Aging Research
Contact:
Cynthia Bens
Jack Guralnik
Usual Gait Speed (UGS) and the Short Physical Performance Battery (SPPB)Lower-extremity functional decline in persons age 65 years and older who have diminished muscle mass and strength and decreased function that is a result of hip fracturePerfO01/03/2014Consultation & Advice
Contact: Lakshmanan KrishnamurtiSickle Cell Pain Diary

Pain intensity and pain interference in pediatric patients with sickle cell disease

PRO02/14/2014Consultation & Advice
National Cancer Institute, National Institutes of Health
Contact:
Pamela Wolters
Plexiform neurofibroma (PN) pain in children and adultsTumor-related pain intensity and tumor-related pain interference in children and adults with neurofibromatosis type 1 (NF-1)PRO03/06/2014Consultation & Advice
Critical Path Institute: PRO Consortium, Cognition Working Group
Contact:
Stephen Coons
 PerfO tool to assess instrumental activities of daily living [IADLs]Day-to-day functioning in adults (≥45 years) with mild cognitive impairment due to Alzheimer's disease (MCI-AD) as quantified by a PerfO assessment of IADLsPerfO03/18/2015Consultation & Advice
Foundation for the National Institutes of Health and ICON
Contact:
Steve Hoffmann
Kellee Howard
FNIH Project - PRO measure for symptoms of HABPSymptoms of hospital-acquired bacterial pneumonia (HABP) and their effect on patients' functioning in adult patients 18 years of age and older with a diagnosis of HABPPROJune 2015Consultation & Advice
Contact:
Shannon Smith
Robert Dworkin
Dennis Turk
QUALITE-PainPain intensity in non-cognitively impaired adults with acute and chronic painPRO8/05/2015Consultation & Advice
Contact:
Anthony Otley
TUMMY-CDDisease activity for pediatric patients with Crohn’s Disease (CD)PRO7/09/2015Consultation & Advice
Contact:
San Keller
PROMIS® Fatigue item bankMeasurement of symptoms and functioning in myalgic encephalomyetlitis (ME)/ Chronic Fatigue Syndrome (CFS)/ Systemic Exertion Intolerance Disease (SEID)PRO10/08/2015Consultation & Advice
Contact:
David Cella
PROMIS® Physical Functioning item bankPhysical functioning in oncologyPRO11/03/15Consultation & Advice
Contact:
David Cella
PROMIS® Physical Functioning item bankPhysical functioning in sarcopeniaPRO11/03/15Consultation & Advice
Contact:
John Spertus
Kansas City Cardio-myopathy Questionnaire (KCCQ)Symptom of heart failure syndrome and their impact on physical limitationsPRO12/21/15Consultation & Advice
Contacts: Marie Hogan
Jeff Sloan
Polycystic Liver Disease Questionnaire (PLD-Q)Symptoms in adult patients with Gigot stage II or III polycystic liver diseasePRO2/08/16Consultation & Advice
Critical Path Institute: PRO Consortium, Rheumatoid Arthritis Working Group
Contact:
Stephen Coons
Fatigue in Rheumatoid ArthritisFatigue severity in adult patients with clinically defined Rheumatoid Arthritis (RA)PRO10/14/16Consultation & Advice
Critical Path Institute: PRO Consortium, Pediatric Asthma Working Group
Contact:
Stephen Coons
Child Asthma DiarySeverity of asthma signs and symptoms in pediatric asthmaPRO6/13/17Consultation & Advice
Critical Path Institute: PRO Consortium, Multiple Sclerosis Working Group
Contact:
Stephen Coons
PROMIS® Physical Functioning item bankPhysical functioning in multiple sclerosisPRO6/21/17Consultation & Advice
Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium Contacts:
Carole Tucker
Christopher Forrest
PROMIS® Pediatric Crohn’s Disease Short Form – Fatigue 10Fatigue in pediatric patients age 8-17 years with Crohn’s DiseasePRO8/09/17Consultation & Advice

*This submission is/has been under parallel FDA/EMA review.
**Qualification stage according to the January 2014 guidance, Qualification Process for Drug Development Tools1. Under the 21st Century Cures Act2enacted on December 13, 2016, new section 507 (“Qualification of Drug Development Tools”) was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act).  The COA DDT Qualification Program is currently working on transitioning the legacy qualification program process and submissions currently in the program to the new section 507 DDT Qualification Process.

2 Details regarding the 21st Century Cures Act can be found at: https://www.congress.gov/bill/114th-congress/house-bill/34/text, with a pdf of the statutory text at https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf. The content section pertinent to this letter is Subtitle B – Advancing New Drug Therapies, Sec. 3011 Qualification of drug development tools, which is largely codified at section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or 21 U.S.C. 357.

 

Page Last Updated: 04/13/2018
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