Interim sample size re-estimation in the IIVOP trial
نویسندگان
چکیده
منابع مشابه
Interim sample size re-estimation in the IIVOP trial
The IIVOP trial is a cross-over trial which examines the effect of the drug ivabridine in reducing pain in an enriched healthy volunteer pain model. The trial was designed based on very limited information, and as such an interim analysis was built into the design to allow the re-estimation of the sample size requirements based on updated trial parameters. The blinded data will be used to asses...
متن کاملSample size re-estimation in clinical trials.
Adaptive clinical trials are becoming very popular because of their flexibility in allowing mid-stream changes of sample size, endpoints, populations, etc. At the same time, they have been regarded with mistrust because they can produce bizarre results in very extreme settings. Understanding the advantages and disadvantages of these rapidly developing methods is a must. This paper reviews flexi...
متن کاملSample size estimation in epidemiologic studies
This review basically provided a conceptual framework for sample size calculation in epidemiologic studies with various designs and outcomes. The formula requirement of sample size was drawn based on statistical principles for both descriptive and comparative studies. The required sample size was estimated and presented graphically with different effect sizes and power of statistical test at 95...
متن کاملFollow up after sample size re-estimation in a breast cancer trial for time to recurrence
In an international trial of premenopausal women with hormone receptor positive operable breast cancer that compares how the timing of surgical oophorectomy and mastectomy affects time to recurrence, we re-evaluated the required sample size near the end of the planned accrual period. We had anticipated that failure probabilities used at the design stage were too high resulting in a loss of powe...
متن کاملInterim analysis and sample size reassessment.
This article deals with sample size reassessment for adaptive two-stage designs based on conditional power arguments utilizing the variability observed at the first stage. Fisher's product test for the p-values from the disjoint samples at the two stages is considered in detail for the comparison of the means of two normal populations. We show that stopping rules allowing for the early acceptan...
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: Trials
سال: 2015
ISSN: 1745-6215
DOI: 10.1186/1745-6215-16-s2-p128