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.

Population / Cohort
Individuals with COPD and asthma
Assessment Type
Exploratory Analyses
Workgroup Leader(s)

Judith C. Maro PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

David Martin MD, MPH; Center for Drug Evaluation and Research, Office of the Center Director, FDA, Silver Spring, MD

Workgroup Members

Catherine A. Panozzo PhD, Elnara Fazio-Eynullayeva MA, David Cole BM, Katherine E. Freitas; Catherine Rogers Murray MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Robert Busch MD, MMSc; Division of Pulmonary, Allergy, and Rheumatology Products; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Kenneth Quinto MD, MPH; Office of Medical Policy; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER