Bayesian central statistical monitoring using finite mixture models in multicenter clinical trials
نویسندگان
چکیده
منابع مشابه
Central statistical monitoring in clinical trials
Background On-site monitoring is a common but time-consuming and expensive activity, with little evidence that it is worthwhile. Centralised statistical monitoring (CSM) is a much cheaper alternative, where data checks are performed by the co-ordinating centre, reducing the need to visit every site. Although some publications have outlined possible methods, few have applied them to data from re...
متن کاملApplication of methods for central statistical monitoring in clinical trials.
BACKGROUND On-site source data verification is a common and expensive activity, with little evidence that it is worthwhile. Central statistical monitoring (CSM) is a cheaper alternative, where data checks are performed by the coordinating centre, avoiding the need to visit all sites. Several publications have suggested methods for CSM; however, few have described their use in real trials. MET...
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چکیده ندارد.
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The need to use rigorous, transparent, clearly interpretable, and scientifically justified methodology for preventing and dealing with missing data in clinical trials has been a focus of much attention from regulators, practitioners, and academicians over the past years. New guidelines and recommendations emphasize the importance of minimizing the amount of missing data and carefully selecting ...
متن کاملCentral statistical monitoring in multicentre clinical trials: developing statistical approaches for analysing key risk indicators
multivariate location ̆R and scatter ̆ R are defined by minimizing the determinant of the covariance matrix and generalized distances, D T R 2 1 ( ̆ ) ̆ ( ̆ ) x x R R , are calculated. The distances follow a n 2 distribution (where n is the multivariate dimension) and define corresponding p-values. Outliers are defined as centres with p-values below a pre-defined threshold (e.g. p<0.05). This method...
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ژورنال
عنوان ژورنال: Contemporary Clinical Trials Communications
سال: 2020
ISSN: 2451-8654
DOI: 10.1016/j.conctc.2020.100566