Figure 2
From: Fool’s gold, lost treasures, and the randomized clinical trial
Impact of minor changes in proportion of patients with target in simulated trials: If a new therapy quintupled survival in patients with a particular target, the 668-patient simulated study was negative if the target was present in 15% of patients (HR=0.81, p=0.06) but was positive if the target was present in just 11 more patients (16.7%) (HR=0.79, p=0.04). Hence, very minor variations in study patient populations can determine whether a trial will be negative vs positive.