Power/sample size calculations for assessing correlates of risk in clinical efficacy trials
نویسندگان
چکیده
منابع مشابه
R Functions for Sample Size and Probability Calculations for Assessing Consistency of Treatment Effects in Multi-Regional Clinical Trials
Multi-regional clinical trials have been widely used for efficient global new drug developments. Due to potential heterogeneity of patient populations, it is critical to evaluate consistency of treatment effects across different regions in a multi-regional trial in order to determine the applicability of the overall treatment effect to the patients in individual regions. Quan et al. (2010) prop...
متن کاملValidation of Instruments for Assessing Drug Safety Management During the Conduction of Clinical Trials
Background The management of drug safety with the collection of reliable safety data during the conduction of clinical trials conduct is essential for the registry and marketing of products. The systematic evaluation of this process, based on objective measures, requires the application of quality instruments. This study was aimed to design and validate eight instruments through the components ...
متن کاملA mixed Bayesian/Frequentist approach in sample size determination problem for clinical trials
In this paper we introduce a stochastic optimization method based ona mixed Bayesian/frequentist approach to a sample size determinationproblem in a clinical trial. The data are assumed to come from a nor-mal distribution for which both the mean and the variance are unknown.In contrast to the usual Bayesian decision theoretic methodology, whichassumes a single decision maker, our method recogni...
متن کاملSample size calculations for randomized controlled trials.
Most informed consent documents for randomized controlled trials implicitly or explicitly promise the prospective participant that the trial has a reasonable chance of answering a medically important question. The medical literature, however, is replete with descriptions of trials that provided equivocal answers to the questions they addressed. Papers describing the results of such studies may ...
متن کاملSample size calculations for micro-randomized trials in mHealth.
The use and development of mobile interventions are experiencing rapid growth. In "just-in-time" mobile interventions, treatments are provided via a mobile device, and they are intended to help an individual make healthy decisions 'in the moment,' and thus have a proximal, near future impact. Currently, the development of mobile interventions is proceeding at a much faster pace than that of ass...
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: Statistics in Medicine
سال: 2016
ISSN: 0277-6715
DOI: 10.1002/sim.6952