P-values, survival analyses and phase II trials
نویسندگان
چکیده
منابع مشابه
Design of Phase II cancer trials evaluating survival probabilities
BACKGROUND Phase II cancer studies are undertaken to assess the activity of a new drug or a new treatment regimen. Activity is sometimes defined in terms of a survival probability, a binary outcome such as one-year survival that is derived from a time-to-event variable. Phase II studies are usually designed with an interim analysis so they can be stopped if early results are disappointing. Most...
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Because of overwhelming evidence of publication bias in psychology, techniques to correct meta-analytic estimates for such bias are greatly needed. The methodology on which the p-uniform and p-curve methods are based has great promise for providing accurate meta-analytic estimates in the presence of publication bias. However, in this article, we show that in some situations, p-curve behaves err...
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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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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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BACKGROUND The risk and course of serum transaminase elevations (TEs) and clinical hepatic serious adverse event (SAE) development in ritonavir-boosted tipranavir (TPV/r) 500/200 mg BID recipients, who also received additional combination antiretroviral treatment agents in clinical trials (TPV/r-based cART), was determined. METHODS Aggregated transaminase and hepatic SAE data through 96 weeks...
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ژورنال
عنوان ژورنال: British Journal of Cancer
سال: 1994
ISSN: 0007-0920,1532-1827
DOI: 10.1038/bjc.1994.232