Bayesian Design of Noninferiority Trials for Medical Devices Using Historical Data
نویسندگان
چکیده
منابع مشابه
Coding System Design for Medicines and Medical Devices in Iran
Background and Aim: The importance of managing medicines and medical devices as vital resources in healthcare industry cannot be ignored. Therefore, the application of coding systems could be of great help in the control of the required processes. This study aims to develop a coding system for medicines and medical devices in Iran. Materials & Methods: This descriptive study was planned to be ...
متن کاملNoninferiority trials
Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin. These trials have a number of inherent weaknesses that superiority trials do not: no internal demonstration of assay sensitivity, no single conservative analysis approach, lack of protection from bias by blinding, and difficulty in specifying...
متن کاملRigor in the design of observational noninferiority trials.
TO THE EDITOR—Fernández-Hidalgo and colleagues report an important observational active-comparator study to address the need for an aminoglycoside antibiotic in the treatment of enterococcal endocarditis [1]. The study is essentially designed to test the noninferiority hypothesis that ampicillin with ceftriaxone is not meaningfully less effective than ampicillin plus gentamicin while being bett...
متن کاملUnderstanding noninferiority trials
Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical...
متن کاملUsing historical data for Bayesian sample size determination
We consider the sample size determination (SSD) problem, which is a basic yet extremely important aspect of experimental design. Specifically, we deal with the Bayesian approach to SSD, which gives researchers the possibility of taking into account pre-experimental information and uncertainty on unknown parameters. At the design stage, this fact offers the advantage of removing or mitigating ty...
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: Biometrics
سال: 2011
ISSN: 0006-341X
DOI: 10.1111/j.1541-0420.2011.01561.x