select_mtd_Ivanova_binary

Select the maximum tolerated dose (MTD) when the trial is completed for binary endpoint using design by Ivanova et al (2009)

In many phase I trials, the design goal is to find the dose associated with a certain target toxicity rate. In some trials, the goal can be to find the dose with a certain weighted sum of rates of various toxicity grades. For others, the goal is to find the dose with a certain mean value of a continuous response. This package provides the setup and calculations needed to run a dose-finding trial with non-binary endpoints and performs simulations to assess design’s operating characteristics under various scenarios. Three dose finding designs are included in this package: unified phase I design (Ivanova et al. (2009) <doi:10.1111/j.1541-0420.2008.01045.x>), Quasi-CRM/Robust-Quasi-CRM (Yuan et al. (2007) <doi:10.1111/j.1541-0420.2006.00666.x>, Pan et al. (2014) <doi:10.1371/journal.pone.0098147>) and generalized BOIN design (Mu et al. (2018) <doi:10.1111/rssc.12263>). The toxicity endpoints can be handled with these functions including equivalent toxicity score (ETS), total toxicity burden (TTB), general continuous toxicity endpoints, with incorporating ordinal grade toxicity information into dose-finding procedure. These functions allow customization of design characteristics to vary sample size, cohort sizes, target dose-limiting toxicity (DLT) rates, discrete or continuous toxicity score, and incorporate safety and/or stopping rules.

Chia-Wei Hsu

UnifiedDoseFinding

Dose-Finding Methods for Non-Binary Outcomes

select_mtd_Ivanova_binary function

<dl> <dt>target</dt>
<dd>the target toxicity rate</dd> <dt>y</dt>
<dd>the number of toxicity patients at each dose level</dd> <dt>n</dt>
<dd>the number of patients enrolled at each dose level</dd></dl>

Arguments

Chia-Wei Hsu, Haitao Pan, Rongji Mu

Author

Select the maximum tolerated dose (MTD) of binary endpoint for single agent trials using design by Ivanova et al (2009) — select_mtd_Ivanova_binary

<dl>

 <dt>target</dt>
<dd>the target toxicity rate</dd>

 <dt>y</dt>
<dd>the number of toxicity patients at each dose level</dd>

 <dt>n</dt>
<dd>the number of patients enrolled at each dose level</dd>

</dl>

select_mtd_Ivanova_binary: Select the maximum tolerated dose (MTD) of binary endpoint for single agent trials using design by Ivanova et al (2009)

Description

Usage

Value

Arguments

Author

References

Examples