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CluePoints - Intelligent Statistical Monitoring White Papers

CluePoints - Intelligent Statistical Monitoring

The Role of Biostatistics in the Prevention, Detection and Treatment of Fraud in Clinical Trials Recent cases of fraud in clinical trials have attracted considerable media attention, but relatively little reaction from the biostatistical community. In this paper we argue that biostatisticians should be involved in preventing fraud (as well as unintentional errors), detecting it, and quantifying its impact on the outcome of clinical trials.
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Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods Errors in the design, the conduct, the data collection process, and the analysis of a randomized trial have the potential to affect not only the safety of the patients in the trial, but also, through the introduction of bias, the safety of future patients. Trial monitoring, defined broadly to include methods of oversight which begin when the study is designed and continue until it is reported in a publication, has a role to play in eliminating such errors.
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A Statistical Approach to Central Monitoring of Data Quality in Clinical Trials 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.
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