PMID- 23845253
OWN - NLM
STAT- MEDLINE
DCOM- 20140602
LR  - 20130930
IS  - 1541-0420 (Electronic)
IS  - 0006-341X (Linking)
VI  - 69
IP  - 3
DP  - 2013 Sep
TI  - Bayesian approach for clinical trial safety data using an Ising prior.
PG  - 661-72
LID - 10.1111/biom.12051 [doi]
AB  - In drug safety, development of statistical methods for multiplicity adjustments 
      has exploited potential relationships among adverse events (AEs) according to 
      underlying medical features. Due to the coarseness of the biological features 
      used to group AEs together, which serves as the basis for the adjustment, it is 
      possible that a single adverse event can be simultaneously described by multiple 
      biological features. However, existing methods are limited in that they are not 
      structurally flexible enough to accurately exploit this multi-dimensional 
      characteristic of an adverse event. In order to preserve the complex dependencies 
      present in clinical safety data, a Bayesian approach for modeling the risk 
      differentials of the AEs between the treatment and comparator arms is proposed 
      which provides a more appropriate clinical description of the drug's safety 
      profile. The proposed procedure uses an Ising prior to unite medically related 
      AEs. The proposed method and an existing Bayesian method are applied to a 
      clinical dataset, and the signals from the two methods are presented. Results 
      from a small simulation study are also presented.
CI  - (c) 2013, The International Biometric Society.
FAU - McEvoy, Bradley W
AU  - McEvoy BW
AD  - Office of Biostatistics, CDER, FDA, 10903 New Hampshire Ave, Silver Spring, 
      Marryland 20993, U.S.A.
FAU - Nandy, Rajesh R
AU  - Nandy RR
FAU - Tiwari, Ram C
AU  - Tiwari RC
LA  - eng
PT  - Journal Article
DEP - 20130711
PL  - England
TA  - Biometrics
JT  - Biometrics
JID - 0370625
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - *Bayes Theorem
MH  - Biometry/methods
MH  - Clinical Trials as Topic/statistics & numerical data
MH  - Computer Simulation
MH  - Databases, Factual/statistics & numerical data
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Markov Chains
MH  - *Models, Statistical
MH  - Monte Carlo Method
OTO - NOTNLM
OT  - Bayes Factor
OT  - Drug safety
OT  - High-dimensional data analysis
OT  - Ising prior
OT  - Markov random field
OT  - MedDRA
EDAT- 2013/07/13 06:00
MHDA- 2014/06/03 06:00
CRDT- 2013/07/13 06:00
PHST- 2012/05/01 00:00 [received]
PHST- 2013/03/01 00:00 [revised]
PHST- 2013/04/01 00:00 [accepted]
PHST- 2013/07/13 06:00 [entrez]
PHST- 2013/07/13 06:00 [pubmed]
PHST- 2014/06/03 06:00 [medline]
AID - 10.1111/biom.12051 [doi]
PST - ppublish
SO  - Biometrics. 2013 Sep;69(3):661-72. doi: 10.1111/biom.12051. Epub 2013 Jul 11.