Statistical analysis of clinical trials with protocol violations.
نویسندگان
چکیده
منابع مشابه
Performing meta-analysis with incomplete statistical information in clinical trials
BACKGROUND Results from clinical trials are usually summarized in the form of sampling distributions. When full information (mean, SEM) about these distributions is given, performing meta-analysis is straightforward. However, when some of the sampling distributions only have mean values, a challenging issue is to decide how to use such distributions in meta-analysis. Currently, the most common ...
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BACKGROUND Excessive protocol violations (PV), which can be defined as preventable mistakes in study conduct, may result in patient harm and introduce errors into a clinical trial's results leading to flawed trial conclusions.The purpose of this project was to gain a better understanding of reported PVs, to describe current practice with regards to the use of methods for the reduction of PVs an...
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In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...
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My object in this lecture will be to give an overview of the statistical aspects of current clinical trial methodology, including a very brief history, my view of current practice, recent relevant statistical developments, and areas that need further statistical research. My primary concern will be clinical experiments, though I will have some comments on other types of study of clinical data a...
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ژورنال
عنوان ژورنال: Japanese Journal of Biometrics
سال: 1997
ISSN: 2185-6494,0918-4430
DOI: 10.5691/jjb.18.99