PMID- 17803255
OWN - NLM
STAT- MEDLINE
DCOM- 20071129
LR  - 20071008
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 16
IP  - 10
DP  - 2007 Oct
TI  - A note on post-marketing safety study design to characterise time-dependent 
      adverse events.
PG  - 1146-52
AB  - PURPOSE: To investigate a suitable post-marketing safety study design, that is 
      number of patients and duration of exposure, to well characterise adverse events 
      (AEs) profiles under limited resources, fixed patient-months. METHODS: A 
      simulation study is conducted to investigate a suitable study design that can 
      appropriately characterise the shape of the hazard function of AEs using the 
      Weibull model. The reliability of the estimates is evaluated by referring their 
      bias and mean squared error (MSE). RESULTS: In general, patients should be 
      followed for a longer period even if the number of patients is relatively small 
      for characterising delayed AEs. Patients' drop-out affects the estimation and 
      deteriorates its reliability. For AEs that are likely to occur soon after the 
      exposure, a study with relatively shorter duration and large number of patients 
      is preferable. CONCLUSIONS: It is important to evaluate statistically the 
      appropriate study design in planning a safety study so that a good estimate of 
      the hazard function would be obtained.
FAU - Narukawa, Mamoru
AU  - Narukawa M
AD  - Division of Pharmaceutical Medicine, Kitasato University Graduate School, Tokyo, 
      Japan. mnarukawa@hkg.odn.ne.jp
FAU - Yafune, Akifumi
AU  - Yafune A
LA  - eng
PT  - Journal Article
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
SB  - IM
MH  - Humans
MH  - Product Surveillance, Postmarketing/*methods
MH  - *Research Design
MH  - Time Factors
EDAT- 2007/09/07 09:00
MHDA- 2007/12/06 09:00
CRDT- 2007/09/07 09:00
PHST- 2007/09/07 09:00 [pubmed]
PHST- 2007/12/06 09:00 [medline]
PHST- 2007/09/07 09:00 [entrez]
AID - 10.1002/pds.1472 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2007 Oct;16(10):1146-52. doi: 10.1002/pds.1472.