Table 3. Likelihood-ratios and decision rules for ‘3+3’ and mTPI designs (per dose level) for scenario C.
| (C) H1: p=0.15 vs H2: p=0.05 | ||||||
|---|---|---|---|---|---|---|
|
| ||||||
| DLT(n)a | ‘3+3’ rule | mTPI ruleb | L(p2)/L(p1) | Evidencec | ||
|
| ||||||
| k=1 | k=2 | k=4 | ||||
| 0(3) | acceptable (E) | acceptable (E) | LR=1.40 | acceptable | weak | weak |
| 0(3)+0(3) | acceptable (E) | acceptable (E) | LR=1.95 | acceptable | weak | weak |
| 1(3)+0(3) | acceptable (E) | acceptable (S) | LR=0.58 | toxic | weak | weak |
| 2(3) | toxic (D) | toxic (D) | LR=0.12 | toxic | toxic | toxic |
| 3(3) | toxic (D) | toxic (D) | LR=0.04 | toxic | toxic | toxic |
| 1(3)+1(3) | toxic (D) | toxic (D) | LR=0.17 | toxic | toxic | toxic |
| 1(3)+2(3) | toxic (D) | toxic (D) | LR=0.05 | toxic | toxic | toxic |
| 1(3)+3(3) | toxic (D) | toxic (D) | LR=0.02 | toxic | toxic | toxic |
Abbreviations: D: de-escalation; S: stay at same dose; E: escalation;
a
Dose limiting toxicities (cohort size)
b
mTPI: modified toxicity probability interval with pT = 0.10 and ε1= ε2=0.05
c
Acceptable: LR ≥ k; Toxic: LR ≤ 1 / k; Weak evidence (favors neither hypothesis): 1 / k < LR < k