param_thetaH0

internal

Design and analysis of confirmatory adaptive clinical trials with continuous, binary, and survival endpoints according to the methods described in the monograph by Wassmer and Brannath (2016) <doi:10.1007/978-3-319-32562-0>. This includes classical group sequential as well as multi-stage adaptive hypotheses tests that are based on the combination testing principle.

Friedrich Pahlke

rpact

Confirmatory Adaptive Clinical Trial Design and Analysis

Gernot Wassmer

Till Jensen

Stephen Schueuerhuis

param_thetaH0 function

<dl><dt>thetaH0</dt>
<dd>The null hypothesis value,
default is <code>0</code> for the normal and the binary case (testing means and rates, respectively),
it is <code>1</code> for the survival case (testing the hazard ratio). 
For non-inferiority designs, <code>thetaH0</code> is the non-inferiority bound.
That is, in case of (one-sided) testing of<ul>
<li>means: a value <code>!= 0</code>
(or a value <code>!= 1</code> for testing the mean ratio) can be specified.</li>
<li>rates: a value <code>!= 0</code>
(or a value <code>!= 1</code> for testing the risk ratio <code>pi1 / pi2</code>) can be specified.</li>
<li>survival data: a bound for testing H0: <code>hazard ratio = thetaH0 != 1</code> can be specified.</li>
</ul>For testing a rate in one sample, a value <code>thetaH0</code> in (0, 1) has to be specified for
defining the null hypothesis H0: <code>pi = thetaH0</code>.</dd></dl>

Arguments

Parameter Description: Theta H0 — param_thetaH0

<dl>

<dt>thetaH0</dt>
<dd>The null hypothesis value,
default is <code>0</code> for the normal and the binary case (testing means and rates, respectively),
it is <code>1</code> for the survival case (testing the hazard ratio). 
For non-inferiority designs, <code>thetaH0</code> is the non-inferiority bound.
That is, in case of (one-sided) testing of<ul>
<li>means: a value <code>!= 0</code>
(or a value <code>!= 1</code> for testing the mean ratio) can be specified.</li>
<li>rates: a value <code>!= 0</code>
(or a value <code>!= 1</code> for testing the risk ratio <code>pi1 / pi2</code>) can be specified.</li>
<li>survival data: a bound for testing H0: <code>hazard ratio = thetaH0 != 1</code> can be specified.</li>
</ul>For testing a rate in one sample, a value <code>thetaH0</code> in (0, 1) has to be specified for
defining the null hypothesis H0: <code>pi = thetaH0</code>.</dd>

</dl>

Parameter Description: Theta H0