Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control

Table 6

Estimated proportions of patients exhibiting DLTs, treated above the MTD, MSE, and bias of the MTD under designs ¹𝑃 and ³𝑃 and differences between these proportions on the average.

	Sample size n
	12		18		24		30
Proportion of DLTs	^1𝑃	0.2546	^1𝑃	0.2580	^1𝑃	0.2607	^1𝑃	0.2616
	^3𝑃	0.2444	^3𝑃	0.2523	^3𝑃	0.2563	^3𝑃	0.2595
	diff.	0.0102	diff.	0.0057	diff.	0.0044	diff.	0.0021
Proportion above the MTD	^1𝑃	0.1895	^1𝑃	0.2001	^1𝑃	0.2040	^1𝑃	0.2067
	^3𝑃	0.1685	^3𝑃	0.1888	^3𝑃	0.1984	^3𝑃	0.2029
	diff.	0.0210	diff.	0.0113	diff.	0.0056	diff.	0.0038
MSE	^1𝑃	0.0427	^1𝑃	0.0394	^1𝑃	0.0371	^1𝑃	0.0351
	^3𝑃	0.0429	^3𝑃	0.0395	^3𝑃	0.0365	^3𝑃	0.0344
	diff.	−𝟎.𝟎𝟎𝟎𝟐	diff.	−𝟎.𝟎𝟎𝟎𝟏	diff.	0.0006	diff.	0.0007
Bias	^1𝑃	0.0186	^1𝑃	0.0190	^1𝑃	0.0181	^1𝑃	0.0193
	^3𝑃	0.0271	^3𝑃	0.0261	^3𝑃	0.0259	^3𝑃	0.0244
	diff.	−𝟎.𝟎𝟎𝟖𝟓	diff.	−𝟎.𝟎𝟎𝟕𝟏	diff.	−𝟎.𝟎𝟎𝟕𝟖	diff.	−𝟎.𝟎𝟎𝟓𝟏