Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a lot of buzz in the industry about how to apply the approach in clinical trials. While many ask the question about how this risk-based approach may reduce the costs of clinical studies by requiring less on-site monitoring of data, it’s also important to ask what the risk is for not going on site.
We’ve addressed this dilemma in IMARC’s newest whitepaper: Centralized vs. Onsite Monitoring: A Sponsor’s Balancing Act Applying a Risk-based Approach.
In theory, a centralized approach to monitoring may reduce short-term costs, and excluding on-site monitoring altogether may prove to have long-term consequences. Centralized and on-site monitoring are not meant to be mutually exclusive; instead, on-site monitoring, combined with an overall centralized review process and excellent communication throughout, results in a high-quality, risk-based approach to identifying and securing compliance that can give sponsors confidence that:
- Patients enrolled in their trials have been protected.
- Their data is accurate.
- Their investigational product can reach the finish line.
Please take time to download IMARC Research’s newest whitepaper. Let us know about your thoughts on this important topic.