| 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 |
