Astellas Pharma Inc, 2-5-1, Nihonbashi-Honcho, Chuo-ku Tokyo, 103-8411, Japan.
Ther Innov Regul Sci. 2020 Jan;54(1):139-143. doi: 10.1007/s43441-019-00037-x. Epub 2020 Jan 6.
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.
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.
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.
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.
近年来，FDA 的《行业指南》推动了基于风险的方法的迅速普及。这种方法有助于更有效地执行临床研究，提高研究质量。
我们开展了一项采用基于风险的监测的试点研究。在准备阶段，我们对该研究（方案层面和项目层面）的风险进行了评估，并尽可能地加以缓解。在研究期间，我们在进行现场（实地/非实地）监测的同时进行集中监测，并根据风险管理计划，根据两种监测的结果评估研究风险。
我们发现，随着研究的进展，现场监测的平均频率降低了。研究完成后，我们接受了医药和医疗器械管理局的检查，但没有发现会影响研究结果和患者安全的重大不符合项。
结果表明，作为一种创新监测方法的基于风险的方法有助于提高研究结果的可靠性，并促进高效监测。
