Facing ever-increasing costs of running a clinical trial, sponsors must ensure they are properly directing their budget and resolving the areas of highest risk while maintaining patient safety and data integrity.
How can sponsors implement a robust process to allow earlier identification of emerging risks during the course of a trial? This article covers five tips for defining risk levels, categorizing risk and maintaining oversight to ensure that risks and responses are appropriately identified, documented, tracked and managed throughout the life cycle of a study.
1 – Defining your levels of risk
风险是在计划，学习水平，站点水平和业务层面发生的任何试验中的自然发生。定义它是获得控制的第一步。在高水平，可以评估研究的整体风险。例如，与低风险期IV观察研究相比，II期肿瘤学研究表明需要更严格的监测策略的风险。
研究风险也可以基于已知的高性能的位点与新网站相同，而新地点对于治疗区域的熟悉程度较小。最后，可以根据实时患者注册数据估算操作风险，以将实际性能与预测进行比较。
2 – Assessing and categorizing risk
With the defined levels of risk at the study, site and operational levels, an overall risk assessment can be created for a protocol and across a program. Covance usesXcellerate® Monitoring，具有独立SaaS的解决方案能够监督强大的风险管理过程。
One module of the platform, the Risk Assessment Categorization Tool, applies an algorithm to create an overall category score based on the probability, impact and detectability of the risks, allowing sponsors to make data-driven decision about the most appropriate intervention levels.
3–专注于风险的关键领域
After risks are categorized, they can also be filtered through the user interface of Xcellerate Monitoring to highlight those with the greatest impact on a study, enabling sponsors to appropriately redirect resources. With Xcellerate Risk and Issue Management all members of the study team are able to create, view and manage issues in real time from a single interface.
For example, if the system identifies key risks as excessive underreporting and patient retention, the sponsor and CRO can work together to ensure they are monitoring and controlling these areas throughout the life of the study. This process enables early implementation of preventive actions and can help minimize quality failures.
4–监测和控制风险
即使具有定义和分类的风险，也必须在研究中监控风险的状态。Covance利用Xcellerate风险审查来聚合电子数据并触发早期检测和行动。
With automatic metrics, the system generates recommendations to increase, decrease or maintain monitoring levels at a site using key risk indicator scoring. This helps the trial’s project team to take action and allows sponsors and CROs to prioritize and target individual sites. The automated process also helps manage escalation paths and fulfills regulatory guidance surrounding adapted and triggered site monitoring.
5 - 评估风险管理的有效性
As risks are identified, categorized and managed over time, sponsors and their supporting CRO can view the cumulative actions taken month over month, assessing their level of effectiveness and determining if the activities performed helped bring a site back to a lower risk level.
理想情况下，赞助商应当看出，随着时间的推移，比例更大的网站正在进入标准和低风险类别，在高风险类别中的网站总体上减少。这种透明度不仅有助于持续改进实践，而且还展示了对监管机构的全部控制和遵守情况。
Creating a comprehensive strategy for risk
通过当今的大型全球试验和虚拟项目团队使用孤立的多个系统，提案国需要一种有效的方法来加速决策并关闭审判监督的差距。在一项研究中统一质量和风险管理或研究组合有助于在成为脱轨试验的系统问题之前揭示信号。
Xcellerate监控界面不同的系统，提供了前所未有的对所有临床试验数据和平台连接的访问。Learn more关于我们如何确保无摩擦的执行我们的临床研究，以有效地遵守您在您的临床研究中的质量管理要求。
