Flexible Approach: There’s No “One Size Fits All” RBM Strategy
PRA understands that individual sponsors have various experience and comfort-level with RBM. Our flexible approach allows PRA and our clients to identify the best study-specific monitoring strategy that aligns with the study-specific risks identified during the Risk Assessment & Planning phase. A variety of factors can influence the overall RBM approach, including:
- Study Phase and Design
- Primary and secondary study objectives
- Safety profile of product/device
- Treatment paradigm and standard of care
- Complexity of study-specific requirements
- Number of sites/patients
- Site profile (i.e., research naïve)
- Study duration (patient retention requirements)
- Geographic regions
Considering the number of factors that determine the best type of monitoring strategy—there is no “one size fits all.” As a result, there is not a set ratio of on-site monitoring versus centralized monitoring. Traditionally, monitors are 100% onsite to review the data every four to six weeks. With RBM, risks and parameters are discussed at the beginning of the study with our clients to understand what the best approach for each protocol.
The below graph depicts the evolution that sponsors typically experience as they transition from 100% SDV to full RBM:
Risk Assessment and Planning
The risk assessment process is an evaluation of risk of each individual study, beginning with a multi-disciplinary team. This process is not only conducted at the onset of a study, but also reevaluated and modified as needed due to changes in study design or standard of care.
There are a number of considerations that should be evaluated during the risk assessment and planning phase. It is especially important to consider the study's critical data points, including the primary study objectives and safety data, as well as the critical processes that impact patient safety and support data quality. The plan should then be developed across functional areas and stakeholders to ensure that all findings of the risk assessment are addressed:
- Identify critical study Data and Processes
- Perform a risk assessment to identify risks to these critical data and processes
- Design a monitoring plan tailored to identified important and likely risks
True RBM employs various approaches to evaluate key data and processes from various sources of a study and take action when required. The key is to ensure it is clearly documented and trigger points are clearly defined and an action plan in place to address each.
Successful Operational Approach
Centralized Monitoring is a key component of any RBM approach and involves the review of data without source documents and completion of other monitoring tasks off-site. When effectively implementing RBM, there is a site management shift from the regional onsite CRA to the highly trained Central monitoring team. This may consist of checks for completeness and consistency of data, analysis of data trends and distribution, identification of protocol violations, evaluation and management of risks, site management and administrative, site training and retraining, and regulatory tasks.
The growing consensus among clinical researchers and regulatory authorities is that RBM is more likely to ensure patient protection and overall study quality and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data verification (SDV).