Risk based monitoring does not reduce the cost of clinical trials
Abstract
The article covers the topics of clinical trial budgeting when applying risk-based monitoring (RBM) model. The problem is that the new monitoring model requires the new model of clinical trail budgeting too, while today, the common practice is to apply an old, traditional fixed-price budgeting.
References
1. Risk-Based Monitoring: Understanding The Future Of Clinical Trial Monitoring. By Lynn King, senior director, clinical operations, TKL Research. Clinical Leader, июнь 2015.
2. RbM Guidance Document: Ten Burning Questions about Risk-Based Study Management. By Moe Alsumidaie, Beat Widler, PhD, Johanna Schenk, MD, PhD, Peter Schiemann, PhD, Artem Andrianov, PhD, Mar?a Proup?n-P?rez, PhD. Applied Clinical Trials, январь 2015.
3. TransCelerate BioPharma. Risk-Based Monitoring.
4. https://cyntegrity.com/products/clinical-trials-with-earlybird/
Review
For citations:
Stefanov I.V. Risk based monitoring does not reduce the cost of clinical trials. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2016;(2):71-72. (In Russ.)
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