The phase II/III transition : Toward the proof of efficacy in cancer clinical trials

摘要: Few phase III investigations show a benefit for an experimental treatment when compared to standard therapy or placebo. This illustrates the need more reliable estimates of effects from II used design definitive trials. In this manuscript, we examine four aspects clinical trial designs: (1) selecting endpoints; (2) defining patient population evaluation; (3) determining level activity that would justify trial; and (4) estimating sample sizes. each area, problems with conventional approaches are discussed alternatives successful transition results setting suggested. An application patients androgen-independent prostate cancer is illustrated.