To investigate the extent to which statistical designs were used in some recent phase ii studies, and which designs were the most common, we did a survey of 145 trials involving treatment of breast cancer. studies selected for the survey were published between 1995 and 1999 in one of seven specific oncology journals (all with impact factor. Several statistical designs for phase ii studies have been proposed, but they are frequently misunderstood or not applied at all. in this review we describe the major characteristics of the available designs. to investigate the extent to which statistical designs were used in some recent phase ii studies, and which designs were the most common, we did a survey of 145 trials involving treatment.
A list of papers describing statistical designs for phase ii clinical trials was produced through a search of pubmed using the following keywords: “clinical trials, phase ii” [mesh major topic]. this list was integrated by hand: we perused more recent literature from the main statistical journals and identified additional papers from the. Traditionally, two stage single arm phase ii trials have been used to assess the activity and toxicity of new single agents. there are several two stage designs for phase ii trials 18,19. simon’s design is a popular option that minimizes exposure of too many patients to ineffective and perhaps too toxic agents 20. a relatively small number of. Perrone f, di maio m, de maio e, maione p, ottaiano a, pensabene m, di lorenzo g, lombardi av, signoriello g, gallo c (2003) statistical design in phase ii clinical trials and its application in. Conclusions: the application of "adaptive clinical designs" for phase ii iii studies appear to have been limited to trials with a small number of study centers, with smaller extensions of time and to experimental drugs with more immediate clinical effects that are amenable to risk benefit decisions based on interim analyses. according to the.
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