Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data

Author:

Nelson Jennifer C.12,Cook Andrea J.12,Yu Onchee1,Dominguez Clara12,Zhao Shanshan2,Greene Sharon K.3,Fireman Bruce H.4,Jacobsen Steven J.5,Weintraub Eric S.6,Jackson Lisa A.7

Affiliation:

1. Biostatistics Unit; Group Health Research Institute; Seattle WA USA

2. Department of Biostatistics; University of Washington; Seattle WA USA

3. Department of Population Medicine; Harvard Medical School and Harvard Pilgrim Health Care Institute; Boston MA USA

4. Kaiser Permanente Division of Research; Oakland CA USA

5. Department of Research and Evaluation; Kaiser Permanente Southern California; Pasadena CA USA

6. Immunization Safety Office; Centers for Disease Control and Prevention; Atlanta GA United States

7. Group Health Research Institute; Seattle WA USA

Funder

FDA through the Department of Health and Human Services

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference32 articles.

1. The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA;Chen;Bull World Health Organ,2000

2. Active surveillance of vaccine safety: a system to detect early signs of adverse events;Davis;Epidemiology,2005

3. The Vaccine Safety Datalink: a model for monitoring immunization safety;Baggs;Pediatrics,2011

4. Developing the Sentinel System - A National Resource for Evidence Development;Behrman;N Engl J Med,2011

5. Methods for observational post-licensure medical product safety surveillance;Nelson;Stat Methods Med Res

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