Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data
Article first published online: 19 JAN 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program
Volume 21, Issue Supplement S1, pages 62–71, January 2012
How to Cite
Nelson, J. C., Cook, A. J., Yu, O., Dominguez, C., Zhao, S., Greene, S. K., Fireman, B. H., Jacobsen, S. J., Weintraub, E. S. and Jackson, L. A. (2012), Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data. Pharmacoepidem. Drug Safe., 21: 62–71. doi: 10.1002/pds.2324
- Issue published online: 19 JAN 2012
- Article first published online: 19 JAN 2012
- FDA through the Department of Health and Human Services. Grant Number: HHSF223200910006I
- 5Methods for observational post-licensure medical product safety surveillance. Stat Methods Med Res (in press)., , , et al.
- 6A maximized sequential probability ratio test for drug and vaccine safety surveillance. Seq Anal 2011; 30: 58–78., , , et al.
- 9on behalf of the Vaccine Safety Datalink Investigation Group. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. Pediatr Infect Dis J 2010; 29(1): 1–5. DOI: 10.1097/INF.0b013e3181af8605, , , et al.
- 12Update: Recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding administration of combination MMRV vaccine. MMWR Morb Mortal Wkly Rep 2008; 57: 258–260., , , et al.
- 14The design and analysis of sequential clinical trials. Wiley: New York, NY, 1997..
- 15Group sequential methods with applications to clinical trials. CRC Press: Boca Raton, FL, 2000., .
- 17Statistical approaches to group sequential monitoring of postmarketing safety surveillance data: Current state of the art for use in the Mini-Sentinel surveillance project. Pharmacoepidemiol Drug Saf 2012; 21(S1): 72–81., , , et al.
- 18Centers for Disease Control and Prevention. Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, and Haemophilus b Conjugate Vaccine and Guidance for Use in Infants and Children. MMWR Morb Mortal Wkly Rep 2008; 57(39): 1079–1080.
- 22Study design considerations in an active medical product safety monitoring system. Pharmacoepidemiol Drug Saf 2012; 21(S1): 32–40., , , et al.
- 29Food and Drug Administration. Product information: package insert. Pentacel (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate [tetanus toxoid conjugate] vaccine. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109810.pdf [29 January 2007].
- 30on behalf of the Pentacel Study Group. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: A randomized, clinical trial. Pediatrics 2009; 123: 301–312. DOI: 10.1542/peds.2007-3317, , , et al.