Central statistical monitoring in 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...
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...
متن کاملA statistical approach to central monitoring of data quality in clinical trials.
BACKGROUND Classical monitoring approaches rely on extensive on-site visits and source data verification. These activities are associated with high cost and a limited contribution to data quality. Central statistical monitoring is of particular interest to address these shortcomings. PURPOSE This article outlines the principles of central statistical monitoring and the challenges of implement...
متن کاملStatistical Monitoring of Clinical Trials: a Unified Approach
In what case do you like reading so much? What about the type of the statistical monitoring of clinical trials a unified approach reprint book? The needs to read? Well, everybody has their own reason why should read some books. Mostly, it will relate to their necessity to get knowledge from the book and want to read just to get entertainment. Novels, story book, and other entertaining books bec...
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: Trials
سال: 2011
ISSN: 1745-6215
DOI: 10.1186/1745-6215-12-s1-a55