DIA 49th Annual Meeting

CTTI

EMA joins FDA in growing movement toward risk-based monitoring of clinical trials

Monday, September 19, 2011 08:02 AM

Along with the FDA and the Clinical Trials Transformation Initiative (CTTI), the European Medicines Agency (EMA) is advocating for risk-based monitoring of trials, while at the same time saying current GCP rules render quality management in trials too costly and need to be reworked.

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FDA’s new guidance on monitoring clinical trials strongly encourages taking a risk-based approach

Monday, September 5, 2011 08:02 AM

Arisk-based approach to monitoring clinical trials: It’s the way to go now.

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CRF Health: Supporting Monitors & Investigators in Clinical Trials, April 25, May 16

CTTI report recommends risk-based monitoring

Monday, August 15, 2011 08:02 AM

Almost 90% of those conducting clinical trials within the commercial drug industry always perform on-site visits to their study sites. In contrast, about a third of academic, government or cooperative groups involved in research do. And yet, neither monitoring method is based on any evidence that it improves the quality of the data, as no such evidence yet exists.

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