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Logo of nihpaAbout Author manuscriptsSubmit a manuscriptHHS Public Access; Author Manuscript; Accepted for publication in peer reviewed journal;
 
From:
Stat Med. Author manuscript; available in PMC 2011 May 10.
Published in final edited form as:
Stat Med. 2010 May 10; 29(10): 1061–1071.
doi: 10.1002/sim.3676

Table 3

Operating characteristics of a 90 endpoint product Phase 2b trial vs a 300 endpoint Phase 3 trial

(a) Decision guideline for Phase 2b design (n = 90 infections)
HarmUselessPlaus EffEff 1 Ph 3Eff 2 Ph 3

Probability of obtaining an estimated V E
True V E≤ −.42> −.42 and ≤ .24> .24 and ≤ .55> .55 and ≤ 1.0> 1.0
−.5.60.40<.001<.001<.001
0.05.85.10<.001<.001
.3<.001.35.63.02<.001
.5<.001.02.66.32<.001
.7<.001<.001.04.96<.001
(b) Decision guideline for Phase 3 design (n = 300 infections)
HarmUselessPlaus EffEff 1 Ph 3Eff 2 Ph 3

Probability of obtaining an estimated V E
True V E≤ −.26> −.26 and ≤ .20> .20 and ≤ .45> .45 and ≤ .53> .53

−.5.94.06<.001<.001<.001
0.02.95.02<.001<.001
.3.<.001.13.84.02<.001
.5<.001<.001.20.49.31
.7<.001<.001<.001<.0011.0
*Bolded entries are correct decisions