scholarly journals Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance

Biometrics ◽  
2015 ◽  
Vol 71 (3) ◽  
pp. 851-858 ◽  
Author(s):  
I. R. Silva ◽  
M. Kulldorff
Keyword(s):  
Sequential Analysis ◽  
Vaccine Safety ◽  
Group Sequential ◽  
Versus Group ◽  
Safety Surveillance ◽  
Post Market ◽  
Group Sequential Analysis

A New Procedure for Group Sequential Analysis in Clinical Trials

Biometrics ◽  
1992 ◽  
Vol 48 (2) ◽  
pp. 373 ◽  
Author(s):  
Bruno Falissard ◽  
Joseph Lellouch
Keyword(s):  
Clinical Trials ◽  
Sequential Analysis ◽  
Group Sequential ◽  
Group Sequential Analysis

scholarly journals Group-sequential analysis may allow for early trial termination: illustration by an intra-observer repeatability study

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Oke Gerke ◽  
Mie H. Vilstrup ◽  
Ulrich Halekoh ◽  
Malene Grubbe Hildebrandt ◽  
Poul Flemming Høilund-Carlsen
Keyword(s):  
Sequential Analysis ◽  
Group Sequential ◽  
Early Trial ◽  
Group Sequential Analysis

scholarly journals Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety Study

2013 ◽  
Vol 177 (2) ◽  
pp. 131-141 ◽  
Author(s):  
Jennifer C. Nelson ◽  
Onchee Yu ◽  
Clara P. Dominguez-Islas ◽  
Andrea J. Cook ◽  
Do Peterson ◽  
...  
Keyword(s):  
Vaccine Safety ◽  
Safety Study ◽  
Group Sequential ◽  
Sequential Methods ◽  
Safety Surveillance ◽  
Group Sequential Methods

Product-Type Probability Bounds of Higher Order

1992 ◽  
Vol 6 (3) ◽  
pp. 349-370 ◽  
Author(s):  
Hentry W. Block ◽  
Tim Costigan ◽  
Allan R. Sampson
Keyword(s):  
Sequential Analysis ◽  
Product Type ◽  
Multivariate Normal ◽  
Group Sequential ◽  
Positive Dependence ◽  
Normal Distributions ◽  
Probability Bounds ◽  
Group Sequential Analysis ◽  
Image Position ◽  
Multivariate Exponential Distribution

GIaz and Johnson [14] introduce ith-order product-type approximations, βi, i =1,…n − 1, for Pn = P(X1 ≤c1, X2 ≤ c2,…Xn≤ cn) and show that Pn≥ βn−1 ≥ βn−2 ≥… ≥ β2 ≥ β1 when X is MTP2. In this article, it is shown thatunder weaker positive dependence conditions. For multivariate normal distributions, these conditions reduce to cov(Xi,Xj) ≥ 0 for 1 ≤ i < j ≤ n and cov(Xi,Xj| Xj−1) ≥ 0 for 1 ≤ i < j − 1, j = 3,…,n. This is applied to group sequential analysis with bivariate normal responses. Conditions for Pn ≥ β3 ≥ β2 ≥β1 are also derived. Bound conditions are also obtained that ensure that product-type approximations are nested lower bounds to upper orthant probabilities P(X1 > C1,…,Xn > cn). It is shown that these conditions are satisfied for the multivariate exponential distribution of Marshall and Olkin [20].

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