Efficacy gap between phase II and subsequent phase III studies in oncology
نویسندگان
چکیده
منابع مشابه
Meta-analysis of randomized phase II trials to inform subsequent phase III decisions
BACKGROUND If multiple Phase II randomized trials exist then meta-analysis is favorable to increase statistical power and summarize the existing evidence about an intervention's effect in order to help inform Phase III decisions. We consider some statistical issues for meta-analysis of Phase II trials for this purpose, as motivated by a real example involving nine Phase II trials of bolus throm...
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The critical decision in drug development is often at the end of phase II, as phase III trials are an expensive undertaking, with the potential for significant corporate and public consequences in the event of a negative phase III trial. Thus, retrospective analyses of the usefulness of phase II trials are welcomed and valued, as illustrated by the study of Goffin et al. (1). In this analysis o...
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ژورنال
عنوان ژورنال: British Journal of Clinical Pharmacology
سال: 2020
ISSN: 0306-5251,1365-2125
DOI: 10.1111/bcp.14237