pgo_tte

Given our parameters this function calculates the probability to go to phase III after the second phase was conducted. The considered strategies are as follows:<ul>
<li><ol>
<li>Strategy: Only best promising treatment goes to phase III</li>
</ol></li>
</ul>

internal

Plan optimal sample size allocation and go/no-go decision rules
for phase II/III drug development programs with time-to-event, binary or
normally distributed endpoints when assuming fixed treatment effects or a
prior distribution for the treatment effect, using methods from Kirchner et al.
(2016) <doi:10.1002/sim.6624> and Preussler (2020). Optimal is in the sense of
maximal expected utility, where the utility is a function taking into account
the expected cost and benefit of the program. It is possible to extend to more
complex settings with bias correction (Preussler S et al. (2020)
<doi:10.1186/s12874-020-01093-w>), multiple phase III trials (Preussler et
al. (2019) <doi:10.1002/bimj.201700241>), multi-arm trials (Preussler et al.
(2019) <doi:10.1080/19466315.2019.1702092>), and multiple endpoints
(Kieser et al. (2018) <doi:10.1002/pst.1861>).

Lukas D. Sauer

drugdevelopR

Utility-Based Optimal Phase II/III Drug Development Planning

Stella Erdmann

Johannes Cepicka

Marietta Kirchner

Meinhard Kieser

pgo_tte function

<dl><dt>HRgo</dt>
<dd>threshold value for the go/no-go decision rule</dd>
<dt>n2</dt>
<dd>total sample size in phase II, must be divisible by 3</dd>
<dt>ec</dt>
<dd>control arm event rate for phase II and III</dd>
<dt>hr1</dt>
<dd>assumed true treatment effect on HR scale for treatment 1</dd>
<dt>hr2</dt>
<dd>assumed true treatment effect on HR scale for treatment 2</dd>
<dt>strategy</dt>
<dd>choose Strategy: 1 ("only best promising"), 2 ("all promising")</dd>
<dt>case</dt>
<dd>different cases: 1 ("nogo"), 21 (treatment 1 is promising, treatment 2 is not), 22 (treatment 2 is promising, treatment 1 is not), 31 (both treatments are promising, treatment 1 is better), 32 (both treatments are promising, treatment 2 is better)</dd></dl>

Arguments

Probability to go to phase III for multiarm programs with time-to-event outcomes — pgo_tte

<dl>

<dt>HRgo</dt>
<dd>threshold value for the go/no-go decision rule</dd>


<dt>n2</dt>
<dd>total sample size in phase II, must be divisible by 3</dd>


<dt>ec</dt>
<dd>control arm event rate for phase II and III</dd>


<dt>hr1</dt>
<dd>assumed true treatment effect on HR scale for treatment 1</dd>


<dt>hr2</dt>
<dd>assumed true treatment effect on HR scale for treatment 2</dd>


<dt>strategy</dt>
<dd>choose Strategy: 1 ("only best promising"), 2 ("all promising")</dd>


<dt>case</dt>
<dd>different cases: 1 ("nogo"), 21 (treatment 1 is promising, treatment 2 is not), 22 (treatment 2 is promising, treatment 1 is not), 31 (both treatments are promising, treatment 1 is better), 32 (both treatments are promising, treatment 2 is better)</dd>

</dl>

pgo_tte: Probability to go to phase III for multiarm programs with time-to-event outcomes

Description

Usage

Value

Arguments

Examples