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.
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