Abstract
Background:
Following the Guidance for Industry by FDA, the concept of risk-based approach has spread rapidly in recent years. It facilitates more effective, efficient, and high-quality clinical study execution.
Method:
We carried out a pilot study that adopted risk-based monitoring. In the preparatory stage, the risks of this study (protocol level and program level) were assessed and mitigated as much as possible. During the study, centralized monitoring were conducted in parallel with site (on-site/off-site) monitoring, and study risks were assessed based on the results of both monitoring in accordance with the risk management plan.
Results:
We found that average on-site monitoring frequency decreased as the study progressed. After study completion, we conducted a Pharmaceutical and Medical Devices Agency inspection but found no significant nonconformance that would have affected the study results and patient safety.
Conclusions:
The results indicate that a risk-based approach, which is an innovative monitoring approach, contributes to the reliability of study results and promotes efficient monitoring.
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Acknowledgments
The authors acknowledge the following individuals for overall consultation and support: Satoshi Saeki (formerly of Astellas Pharma Global Development Inc, Chicago, IL, now with Astellas Pharma Inc, Tokyo, Japan), Hiroyuki Izutsu (Astellas Pharma Inc, Tokyo, Japan), Takayuki Abe (formerly with Astellas Pharma Inc, Tokyo, Japan, now with Astellas Pharma Global Development Inc, Chicago, IL), and Keiichi Sawachi (Astellas Pharma Inc, Tokyo, Japan).
The authors acknowledge the support of all CRAs and study team members involved in this study for their contributions.
Funding
This study was sponsored by Astellas Pharma Inc, Japan.
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Ayano Higa, Michie Yagi, Kenta Hayashi, and Masanori Kosako are all employees of Astellas Pharma Inc, Japan. Hiraku Akiho was an employee of Astellas Pharma Inc, Japan during the course of this study.
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Higa, A., Yagi, M., Hayashi, K. et al. Risk-Based Monitoring Approach to Ensure the Quality of Clinical Study Data and Enable Effective Monitoring. Ther Innov Regul Sci 54, 139–143 (2020). https://doi.org/10.1007/s43441-019-00037-x
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DOI: https://doi.org/10.1007/s43441-019-00037-x