Controlled clinical trials
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Control Clin Trials · Aug 2000
The phase II/III transition. Toward the proof of efficacy in cancer clinical trials.
Few phase III investigations show a benefit for an experimental treatment when compared to a standard therapy or placebo. This illustrates the need for more reliable estimates of treatment effects from the phase II investigations used to design the more definitive phase III trials. ⋯ In each area, problems with the conventional approaches are discussed and alternatives for the successful transition of phase II results to a phase III setting are suggested. An application of the design for patients with androgen-independent prostate cancer is illustrated.