When should case-only designs be used for safety monitoring of medical products?-Reference-Cited by-同舟云学术

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When should case-only designs be used for safety monitoring of medical products?

Published:2012-01 Issue: Volume:21 Page:50-61
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Maclure Malcolm¹²,Fireman Bruce³,Nelson Jennifer C.⁴⁵,Hua Wei⁶,Shoaibi Azadeh⁶,Paredes Antonio⁶,Madigan David⁷

Affiliation:

1. Department Anesthesiology, Pharmacology and Therapeutics; University of British Columbia; Vancouver BC Canada

2. Pharmaceutical Services Division; BC Ministry of Health; Victoria BC Canada

3. Division of Research; Kaiser Permanente; Oakland CA USA

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

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

6. Food and Drug Administration; Rockville MD USA

7. Statistics Department; Columbia University; New York NY USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.2330/fullpdf

Reference20 articles.

1. Relative incidence estimation from case series for vaccine safety evaluation;Farrington;Biometrics,1995

2. Tutorial in biostatistics: the self-controlled case series method;Whitaker;Stat Med,2006

3. Case series analysis for censored, perturbed, or curtailed post-event exposures;Farrington;Biostatistics (Oxford, England),2009

4. The case-crossover design: a method for studying transient effects on the risk of acute events;Maclure;Am J Epi,1991

5. Should we use a case-crossover design?;Maclure;Ann Rev Public Health,2000

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