In clinical development of new drugs, investment increases over time—Phase III investment can be up to hundreds of millions of dollars. However, some drugs failed because the treatment effect in Phase
Sample size required to conclude non-inferiority (maximum tolerated difference = 4%) of 2R20, or 2R30 in terms of grade 3–5 events compared to 4R10 with a power of 80% and α = 0.05.