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

Project Title COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies
Date Posted
Tuesday, November 6, 2018
Status
In progress
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 will conduct descriptive analyses that will include exploration of cohort definitions, medication utilization, and effectiveness outcomes, and will also attempt to replicate selected standard definitions for COPD and asthma cohorts.

Health Outcome
asthma
chronic obstructive pulmonary disease
Population / Cohort
Individuals with COPD or asthma
Time Period
August 2018 - August 2024
Assessment Type
Exploratory Analyses
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

Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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