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COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies

Basic Details
Date Posted
Status
Complete
Health Outcome(s)
asthma
chronic obstructive pulmonary disease
Description

The main goal of this activity is to leverage existing Sentinel data and tools to perform feasibility assessments for subsequent chronic obstructive pulmonary disease (COPD) and asthma comparative effectiveness studies. The workgroup conducted descriptive analyses that include exploration of cohort definitions, medication utilization, and effectiveness outcomes, and attempted to replicate selected standard definitions for COPD and asthma cohorts.

  • Report 1 includes data from January 1, 2008 to August 31, 2018. We distributed this request to 15 Sentinel Data Partners on May 10, 2019.
  • Report 2 includes data from January 1, 2008 to April 30, 2019. We distributed this request to 13 Sentinel Data Partners on August 14, 2019.
  • Report 3 includes data from January 1, 2000 to July 31, 2019. We distributed this request to 14 Sentinel Data Partners on December 30, 2019.
  • Report 4 includes data from January 1, 2008 to September 30, 2019. We distributed this request to 14 Sentinel Data Partners on March 23, 2020.
  • Report 5 includes data from January 1, 2008 to February 29, 2020. We distributed this request to 15 Sentinel Data Partners on September 3, 2020.
  • Report 6 includes data from March 1, 2011 to March 31, 2020. We distributed this request to 15 Sentinel Data Partners on March 10, 2021.
  • Report 7 includes data from March 1, 2011 to December 31, 2019. We distributed this request to 15 Sentinel Data Partners on April 27, 2021.
Deliverables (7)
Sentinel Modular Program Report: COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies, Report 1 Sentinel Modular Program Report: COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies, Report 2 Sentinel Modular Program Report: COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies, Report 3 Sentinel Modular Program Report: COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies, Report 4 Sentinel Modular Program Report: COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies, Report 5 Sentinel Modular Program Report: COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies, Report 6 Sentinel Modular Program Report: COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies, Report 7
Additional Details
FDA Center
CDER
Time Period
January 1, 2008 - August 31, 2018; January 1, 2008 - April 30, 2019; January 1, 2000 - July 31, 2019; January 1, 2008 - September 30, 2019; January 1, 2008 - February 29, 2020; March 1, 2011 - March 31, 2020; March 1, 2011 - December 31, 2019
Analysis Type
Custom Code
Population / Cohort
Individuals with COPD or asthma
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Comparative Effectiveness of Azithromycin Relative to Roflumilast in Individuals With Uncontrolled Chronic Obstructive Pulmonary Disease Despite Triple Inhaled Therapy
Effectiveness of Fixed Triple Combination Inhaled Corticosteroid (ICS), Long-Acting Beta-Agonist (LABA), and Long-Acting Muscarinic Antagonist (LAMA) Products vs. Multiple Inhaler ICS, LABA, LAMA Therapy in Patients With COPD
Workgroup Leader(s)

Catherine A. Panozzo, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

David Martin, MD, MPH; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Workgroup Members

Inna Dashevsky, MS; Sandra DeLuccia, MPH; Elnara Fazio-Eynullayeva, MA; Katherine Freitas; Judith C. Maro, PhD; Tancy Zhang, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Robert Busch, MD, MMSc; Stacy Chin, MD; Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Kenneth Quinto, MD, MPH; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Jianmeng Chen, MD; Yunzhao Ren, MD; Division of Cancer Pharmacology, U.S. Food and Drug Administration, Silver Spring, MD

Efe Eworuke, PhD; Marie Bradley, PhD, MScPH, MPharm; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Sally Seymour, MD; Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Beltsville, MD

Yan Li, PhD; Zhong Wang, PhD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Rongmei Zhang; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD