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We describe an interactive Fortran program which performs computations related to the design and analysis of group sequential clinical trials using Lan-DeMets spending functions.
We derive flexible designs which have equivalent rejection and acceptance regions if no adaptation is performed, but at the same time allow for an adaptation of the spending functions, and have a conditional optimality property.
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Rather, it is segmented into 12 appropriations subcommittees, and the oversight function is separate from the spending function.
There are also different methods that have been proposed to fit a two-sided design for a given error spending function.
Design operating characteristics of these two methods are compared over a wide range of commonly used size, power and error spending function combinations.
In addition to determining sequential boundaries using an alpha spending function, the program can perform power computations, compute probabilities associated with a given set of boundaries, and generate confidence intervals.
The spending function approach specifies a sequential design directly in terms of α t, the significance levels for interim and final analyses which depend on the amount of hitherto accumulated information in terms of observations gathered.
Differences in SUVmax were assumed to be normally distributed, and sequential one-sided hypothesis tests on the population standard deviation of the differences against a hypothesised value of 1.5 were performed, employing an alpha spending function.
We planned to use the Lan-Demets spending function [18] with O'Brien-Fleming type boundaries [19] to control the type I error for concluding effectiveness at the one-sided 0.025 level.
To maintain the alpha, an O'Brien-Flemming alpha spending function [ 40] will be used.
The Lan-DeMets alpha spending function was employed for major outcomes.
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