PMID- 23331232
OWN - NLM
STAT- MEDLINE
DCOM- 20131025
LR  - 20130121
IS  - 1520-5711 (Electronic)
IS  - 1054-3406 (Linking)
VI  - 23
IP  - 1
DP  - 2013
TI  - A Bayesian group sequential approach to safety signal detection.
PG  - 213-30
LID - 10.1080/10543406.2013.736813 [doi]
AB  - Clinical safety data, usually reported as clinically manifested adverse events 
      (AEs) according to the Medical Dictionary for Regulatory Activities (MedDRA), are 
      routinely collected during the course of a clinical trial involving comparative 
      groups, and periodical monitoring of the safety events is often required to 
      determine whether excessive occurrence of a set of AEs is associated with 
      treatment. To accommodate the structure of reported AEs with the MedDRA system, a 
      Bayesian hierarchical model has been proposed for the analysis of clinical safety 
      data. However, the characteristics of sequential use of the Bayesian method has 
      not been studied. In this paper the Bayesian hierarchical model is applied in a 
      group sequential manner for multiple interim analyses of safety events. A 
      decision-theoretic approach is employed to determine threshold values in the 
      safety signaling process. The proposed approach is illustrated through 
      simulations and a real example.
FAU - Chen, Wenfeng
AU  - Chen W
AD  - Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 
      China.
FAU - Zhao, Naiqing
AU  - Zhao N
FAU - Qin, Guoyou
AU  - Qin G
FAU - Chen, Jie
AU  - Chen J
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Biopharm Stat
JT  - Journal of biopharmaceutical statistics
JID - 9200436
RN  - 0 (Measles-Mumps-Rubella Vaccine)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems/standards
MH  - Bayes Theorem
MH  - Humans
MH  - Measles-Mumps-Rubella Vaccine/adverse effects
MH  - Randomized Controlled Trials as Topic/adverse effects/methods
MH  - *Research Design/standards
MH  - *Signal Detection, Psychological
EDAT- 2013/01/22 06:00
MHDA- 2013/10/26 06:00
CRDT- 2013/01/22 06:00
PHST- 2013/01/22 06:00 [entrez]
PHST- 2013/01/22 06:00 [pubmed]
PHST- 2013/10/26 06:00 [medline]
AID - 10.1080/10543406.2013.736813 [doi]
PST - ppublish
SO  - J Biopharm Stat. 2013;23(1):213-30. doi: 10.1080/10543406.2013.736813.