In anticipation of German ePharma Day on the 26th of June which is focused on “Risk-Based Monitoring in Clinical Trials”, ARITHMOS is looking at how to implement data visualization and analytics tools and strategics to enhance risk-based monitoring.
RBM combines on-site monitoring with centralized remote monitoring supported by the study biometrics team (e.g. Data Managers, Statisticians, etc.). The RBM strategy should be considered in the protocol design stage, and therefore Data Managers can include RBM in the Data Management Plan and Statisticians can plan accordingly for their analyses.
The key factors in RBM are:
- Patient Safety
- Data quality/integrity
- Protocol adherence/deviations
- Monitoring time/cost efficiency
Therefore, monitoring is not only the responsibility of the Monitor, it becomes a cross-functional activity shared among different functions who handle data. Successfully managing a Risk-Based Monitoring approach requires metrics and reports tailored according to risk indicators as well as reporting, analysis and visualization technology solutions.
Centralized/off-site monitoring can be supported by data taken from:
- EDC systems
- Safety databases
- Study documentation
In a typical scenario, data and reports are taken individually from various systems. It makes it difficult to analyze the data for critical key factors and protocol adherence and to then make timely decisions according to the risk mitigation plan.
A solution allows those involved in RBM to create the information they need, share that information and analyze it in order to make crucial decisions such as when to trigger a monitoring visit when data comes in above or below thresholds or highlighting non-performing sites at the earliest time.
Business Intelligence tools are the best technology option for Risk-Based Monitoring. They allow for data retrieval, report development from different data sources, report delivery and cloud-based technology. Web-based applications can be accessed from various devices including PC/laptops, smartphones and tablets. It is important to note that these tools are also visualization and analytics tools which have additional features to support RBM. Some distinct features for RBM include:
- Birthdays and Initials: match subjects based on birthdates or initials to identify subjects that enroll in study more than once
- Perfect Schedule Attendance: Perfect scheduling based on expected study visits may be too good to be true.
- Duplicate Records: identifying a set of test values that are repeated within or across subjects can indicate a problem.
In cases of IMP studies, data are available from previous studies, and often times this data is not used. Business Intelligence tools can pull data from the data warehouse in order to complete risk assessments and define critical data and processes.
Data, reports and analysis are key factors in an efficient application or RBM. A Business Intelligence solution can support ongoing monitoring through ad-hoc reporting, analysis capabilities, visualization, real-time data availability and information sharing. These tools can also support new studies by accessing historical data, better identifying risk factors and thresholds and better designing study protocols.
If you are interested in technology solutions such as Electronic Data Capture and Data Visualization tools for your Risk-Based Monitoring strategy, please contact us at firstname.lastname@example.org.