## [1] "TDsamplesDesign"A logistic log normal model will describe the relationship between dose and DLAE: \[ p(Tox | d) = f(X = 1 | \theta, d) = \frac{e^{\phi_1 + \phi_2 \cdot log(d)}}{1 + e^{\phi_1 + \phi_2 \cdot log(d)}} \]The prior is expressed in terms of pseudo data and, consequently, the number of cases and of DLAEs need not be whole numbers.
The pseudo data are defined in the following table:
| Dose | N | DLAEs |
|---|---|---|
| 25 | 3 | 1.05 |
| 300 | 3 | 1.80 |
No observed data has yet been recorded.
Together, the pseudo and observed data give rise to the following posterior for the model parameters:
\[ \boldsymbol\phi = \begin{bmatrix}\phi_1 \\ \phi_2\end{bmatrix}\sim N \left(\begin{bmatrix}-1.95 \\ 0.41\end{bmatrix} , \begin{bmatrix} 10.05 & -2.08 \\ -2.08 & 0.46\end{bmatrix} \right) \]
≥ 36 patients dosed: If 36 or more participants have been treated.
| Min | Max | Increment |
|---|---|---|
| 25 | 300 | 2 |
| 300 | Inf | 2 |
Placebo will not be administered in the trial.
The dose recommended for the next cohort will be the one which is both eligible and which is the highest dose in the dose grid strictly less than the dose (which may not be in the dose grid) that has a full Bayes posterior estimate of the probability of toxicity exactly equal to the target toxicity rate, either during [0.35] or at the end of the trial [0.3].
A constant size of 3 participants.
No participants are yet evaluable.
The dose grid is 25, 50, 75, 100, 125, 150, 175, 200, 225, 250, 275 and 300.
The starting dose is 25.