estimation_b

This function estimates the correlation between two binary endpoints based on blinded data.

internal

Endpoint selection and sample size reassessment for multiple binary endpoints based on blinded and/or unblinded data. Trial design that allows an adaptive modification of the primary endpoint based on blinded information obtained at an interim analysis. The decision rule chooses the endpoint with the lower estimated required sample size. Additionally, the sample size is reassessed using the estimated event probabilities and correlation between endpoints. The implemented design is proposed in Bofill Roig, M., Gómez Melis, G., Posch, M., and Koenig, F. (2022). <doi:10.48550/arXiv.2206.09639>.

Marta Roig

eselect

Adaptive Clinical Trial Designs with Endpoint Selection and
Sample Size Reassessment

Marta Bofill Roig

Guadalupe Gomez Melis

Franz Koenig

Martin Posch

estimation_b function

<dl><dt>samplesize</dt>
<dd>numeric parameter, sample size per arm</dd>
<dt>p0_e1</dt>
<dd>numeric parameter, probability of occurrence E1 in the control group</dd>
<dt>p1_e1</dt>
<dd>numeric parameter, probability of occurrence E1 in the treatment group</dd>
<dt>OR1</dt>
<dd>numeric parameter, Odds ratio for the endpoint 1 (design)</dd>
<dt>p0_e2</dt>
<dd>numeric parameter, probability of occurrence E2 in the control group</dd>
<dt>p1_e2</dt>
<dd>numeric parameter, probability of occurrence E2 in the treatment group</dd>
<dt>OR2</dt>
<dd>numeric parameter, Odds ratio for the endpoint 2 (design)</dd>
<dt>p0_ce</dt>
<dd>numeric parameter, probability of occurrence composite endpoint in the control group</dd>
<dt>p1_ce</dt>
<dd>numeric parameter, probability of occurrence composite endpoint in the treatment group</dd></dl>

Arguments

Blinded estimation of the correlation — estimation_b

<dl>

<dt>samplesize</dt>
<dd>numeric parameter, sample size per arm</dd>


<dt>p0_e1</dt>
<dd>numeric parameter, probability of occurrence E1 in the control group</dd>


<dt>p1_e1</dt>
<dd>numeric parameter, probability of occurrence E1 in the treatment group</dd>


<dt>OR1</dt>
<dd>numeric parameter, Odds ratio for the endpoint 1 (design)</dd>


<dt>p0_e2</dt>
<dd>numeric parameter, probability of occurrence E2 in the control group</dd>


<dt>p1_e2</dt>
<dd>numeric parameter, probability of occurrence E2 in the treatment group</dd>


<dt>OR2</dt>
<dd>numeric parameter, Odds ratio for the endpoint 2 (design)</dd>


<dt>p0_ce</dt>
<dd>numeric parameter, probability of occurrence composite endpoint in the control group</dd>


<dt>p1_ce</dt>
<dd>numeric parameter, probability of occurrence composite endpoint in the treatment group</dd>

</dl>

estimation_b: Blinded estimation of the correlation

Description

Usage

Value

Arguments