Resampling Phase III Data to Assess Phase II Trial Designs and Endpoints
نویسندگان
چکیده
منابع مشابه
Resampling phase III data to assess phase II trial designs and endpoints.
PURPOSE The best phase II design and endpoint for growth inhibitory agents is controversial. We simulated phase II trials by resampling patients from a positive (sorafenib vs. placebo; TARGET) and a negative (AE941 vs. placebo) phase III trial in metastatic renal cancer to compare the ability of various designs and endpoints to predict the known results. EXPERIMENTAL DESIGN A total of 770 and...
متن کاملChoosing phase II endpoints and designs: evaluating the possibilities.
Selecting the phase II design and endpoint to achieve the best possible chance of success for a confirmatory phase III study in a particular disease and treatment setting is challenging but critical. Simulating from existing clinical trial data sets and from mathematical models can be useful tools for evaluating statistical properties.
متن کاملBiomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review
Biomarker-guided treatment is a rapidly developing area of medicine, where treatment choice is personalised according to one or more of an individual's biomarker measurements. A number of biomarker-guided trial designs have been proposed in the past decade, including both adaptive and non-adaptive trial designs which test the effectiveness of a biomarker-guided approach to treatment with the ai...
متن کاملExamining heterogeneity in phase II trial designs may improve success in phase III.
T he failure rate for late-stage clinical trials in oncology is higher than that for any other area of medicine. Between 1991 and 2000, for example, 55% of phase III trials in oncology failed, compared with 30% in infectious disease and 20% in cardiology, according to a study by Schering-Plough and Merck investigators. A separate study from researchers at Princess Margaret Hospital in Toronto e...
متن کاملIdentifying appropriate phase II trial designs
The phase II to III transition in the drug development process is associated with the highest risk compared to transition rates between other phases [1]. With increasing pressure to improve efficiency in this process it is essential that phase II trials are designed based on informed decisions, and to provide reliable results. With over 120 different phase II trial designs available [2], identi...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Clinical Cancer Research
سال: 2012
ISSN: 1078-0432,1557-3265
DOI: 10.1158/1078-0432.ccr-11-1815