PMID- 31912927
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20210621
IS  - 1097-0258 (Electronic)
IS  - 0277-6715 (Linking)
VI  - 39
IP  - 7
DP  - 2020 Mar 30
TI  - An evaluation of statistical approaches to postmarketing surveillance.
PG  - 845-874
LID - 10.1002/sim.8447 [doi]
AB  - Safety of medical products presents a serious concern worldwide. Surveillance 
      systems of postmarket medical products have been established for continual 
      monitoring of adverse events (AEs) in many countries, and the proliferation of 
      electronic health record systems further facilitates continual monitoring for 
      AEs. We review existing statistical methods for signal detection that are mostly 
      in use in postmarketing safety surveillance of spontaneously reported AEs and we 
      study their performance characteristics by simulation. We compare those with the 
      likelihood ratio test (LRT) method (appropriately modified for use in 
      pharmacovigilance) and use three different methods to generate data (AE based, 
      drug based, and a modification of the method of Ahmed et al). Performance metrics 
      include type I error, power, sensitivity, and false discovery rate, among others. 
      The results show superior performance of the LRT method in almost all simulation 
      experiments. An application to the FDA Adverse Event Reporting System database is 
      illustrated using rhabdomyolysis-related preferred terms reported to FDA during 
      the third-quarter of 2014 to the first-quarter of 2017 for statin drugs. We 
      present a critical discussion and recommendations for use of these methods.
CI  - (c) 2020 John Wiley & Sons, Ltd.
FAU - Ding, Yuxin
AU  - Ding Y
AD  - Department of Biostatistics, State University of New York at Buffalo, Buffalo, 
      New York.
FAU - Markatou, Marianthi
AU  - Markatou M
AUID- ORCID: 0000-0002-1453-8229
AD  - Department of Biostatistics, State University of New York at Buffalo, Buffalo, 
      New York.
FAU - Ball, Robert
AU  - Ball R
AD  - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, 
      U.S. Food & Drug Administration, Silver Spring, Maryland.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20200108
PL  - England
TA  - Stat Med
JT  - Statistics in medicine
JID - 8215016
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Databases, Factual
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Humans
MH  - Likelihood Functions
MH  - Pharmacovigilance
MH  - Product Surveillance, Postmarketing
OTO - NOTNLM
OT  - adverse event identification
OT  - likelihood ratio test
OT  - pharmacovigilance
OT  - postmarketing surveillance
OT  - signal detection
EDAT- 2020/01/09 06:00
MHDA- 2021/06/22 06:00
CRDT- 2020/01/09 06:00
PHST- 2019/01/09 00:00 [received]
PHST- 2019/08/01 00:00 [revised]
PHST- 2019/11/24 00:00 [accepted]
PHST- 2020/01/09 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/01/09 06:00 [entrez]
AID - 10.1002/sim.8447 [doi]
PST - ppublish
SO  - Stat Med. 2020 Mar 30;39(7):845-874. doi: 10.1002/sim.8447. Epub 2020 Jan 8.