Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct

Conclusions:
We recommend a cross-functional, collaborative approach to statistical monitoring that can adapt to study design and data source and use a combination of statistical screening techniques and confirmatory graphics.

Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Knepper, D., Lindblad, A. S., Sharma, G., Gensler, G. R., Manukyan, Z., Matthews, A. G., Seifu, Y. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research