The hazards of randomized phase II trials
نویسندگان
چکیده
منابع مشابه
Design issues of randomized phase II trials and a proposal for phase II screening trials.
Future progress in improving cancer therapy can be expedited by better prioritization of new treatments for phase III evaluation. Historically, phase II trials have been key components in the prioritization process. There has been a long-standing interest in using phase II trials with randomization against a standard-treatment control arm or an additional experimental arm to provide greater ass...
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Single-arm two-stage designs are commonly used in phase II of clinical trials. However, the use of randomization in phase II trials is currently increasing. We propose a randomized version of a Bayesian two-stage design due to Tan and Machin [2]. The idea is to select the two-stage sample sizes by ensuring a large posterior probability that the true response rate of the experimental treatment e...
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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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Almost all trials with a censored time-to-event outcome are designed, powered and analysed with a target hazard ratio for comparing experimental and control treatments in mind. Differences in survival experience between trial arms are tested with a logrank test and usually illustrated using a Kaplan-Meier plot. We describe this as an analysis in the probability domain. The focus is often on est...
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PURPOSE Testing agents in cancers with multiple disease subtypes, in which the activity of a new treatment may vary between subtypes, presents statistical and logistical challenges. We propose a flexible phase II strategy which includes both analyses for each histology or stratum and a combined analysis which borrows information from all the patients in the study. Sequential futility analyses a...
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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2012
ISSN: 0923-7534
DOI: 10.1093/annonc/mdr567