At PAREXEL, we frequently get asked questions about protocol optimization – what it is, how it works, and trends in…
Data-Driven Monitoring is a new paradigm leveraging technology and teamwork to improve study quality and better control costs. Instead of relying on rigidly scheduled Clinical Research Associate (CRA) visits to sites, DDM establishes real-time data surveillance and adaptive monitoring as key governing principles for site and study monitoring. With regulatory guidance in place and powerful DDM tools emerging, it is possible for sponsors to implement DDM strategies to improve quality and reduce monitoring costs.
Generally, there are several operational factors that must be considered when implementing DDM, including:
• Remote Monitoring: Can workload be managed by in-house monitoring?
• Milestones: Has significant time elapsed since the last visit?
• Triggers: Are there any trigger factors which over-ride the prioritization?
• Location: Is the site located close to other sites with high prioritization?
A fair amount has been learned about DDM execution. PAREXEL experience suggests the following elements are critical in achieving DDM success:
• Monitoring need = Workload + Risk + Triggers + Relationship
• Defining and measuring risk, thresholds, and actions are crucial for operational success and cost effectiveness.
• Flexibility in risk indicators and scoring is imperative.
• Focus of monitoring constantly changes and requires ongoing flexibility in the definition of risk and associated action plan.
• Increase pressure for flexibility in resourcing.
• Need to demonstrate that appropriate oversight has been taken.
• Data-driven monitoring affects a wide group of stakeholders.
Given the power of data gathering tools, there is a temptation to over-collect data and bombard CRAs and the support team with an avalanche of data. Care should be taken to track only those data that are important, and to use appropriate visualization tools that distill the data into readily understood information, usually presented in intuitive graphic form.
We want to hear from you! What are your biggest challenges and priorities when considering the implementation of a risk based monitoring solution?
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Global Drug Development