Stopping rules, interim analyses and data monitoring committees
نویسندگان
چکیده
منابع مشابه
Standard 3: data monitoring committees.
Children are generally regarded as “vulnerable individuals.” There has long been reluctance to perform research in children except in limited settings such as pediatric cancer and vaccine development. However, avoidance of trials in children has resulted in uncertainty regarding efficacy, safety, appropriate formulations, and dosages of treatments in pediatric populations, a situation now recog...
متن کاملData monitoring committees: history and their future
Data Monitoring Committees (DMCs), sometimes referred to as Data & Safety Monitoring Boards, have had a successful history over four decades in both government and industry sponsored trials. Their primary mission is to independently evaluate the accumulating data in an on-going clinical for the risks and benefits on behalf of trial participants, investigators, sponsors and regulators. DMCs can ...
متن کاملA systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
BACKGROUND Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials. ...
متن کاملAn analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.
OBJECTIVES To investigate the frequency of interim analyses, stopping rules, and data safety and monitoring boards (DSMBs) in protocols of randomized controlled trials (RCTs); to examine these features across different reasons for trial discontinuation; and to identify discrepancies in reporting between protocols and publications. STUDY DESIGN AND SETTING We used data from a cohort of RCT pro...
متن کاملInterim Monitoring of Clinical Trials: Decision Theory, Dynamic Programming and Optimal Stopping
It is standard practice to monitor clinical trials with a view to stopping early if results are sufficiently compelling. We explain how the properties of stopping boundaries can be calculated numerically and how to optimise boundaries to minimise expected sample size while controlling type I and II error probabilities. Our optimisation method involves the use of dynamic programming to solve Bay...
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ژورنال
عنوان ژورنال: British Journal of Cancer
سال: 1993
ISSN: 0007-0920,1532-1827
DOI: 10.1038/bjc.1993.481