Medical records-based postmarketing safety evaluation of rare events with uncertain status.

TitleMedical records-based postmarketing safety evaluation of rare events with uncertain status.
Publication TypeJournal Article
Year of Publication2013
AuthorsCao, Hongyuan, Lisa M. LaVange, Joseph F. Heyse, Christopher T Mast, and Michael R. Kosorok
JournalJ Biopharm Stat
Volume23
Issue1
Pagination201-12
Date Published2013
ISSN1520-5711
KeywordsHumans, Infant, Intussusception, Medical Records, Normal Distribution, Patient Safety, Product Surveillance, Postmarketing, Randomized Controlled Trials as Topic, Rotavirus Vaccines, Vaccines, Attenuated
Abstract

We develop a simple statistic for comparing rates of rare adverse events between treatment groups in postmarketing safety studies where the events have uncertain status. In this setting, the statistic is asymptotically equivalent to the logrank statistic, but the limiting distribution has Poisson and binomial components instead of being Gaussian. We develop two new procedures for computing critical values, a Gaussian approximation and a parametric bootstrap. Both numerical and asymptotic properties of the procedures are studied. The test procedures are demonstrated on a postmarketing safety study of the RotaTeq vaccine. This vaccine was developed to reduce the incidence of severe diarrhea in infants.

DOI10.1080/10543406.2013.735783
Alternate JournalJ Biopharm Stat
Original PublicationMedical records-based postmarketing safety evaluation of rare events with uncertain status.
PubMed ID23331231
PubMed Central IDPMC3557815
Grant ListP01 CA142538-02 / CA / NCI NIH HHS / United States
P01 CA142538 / CA / NCI NIH HHS / United States
CA142538 / CA / NCI NIH HHS / United States
P01 CA142538-01 / CA / NCI NIH HHS / United States
P01 CA142538-03 / CA / NCI NIH HHS / United States
Project: