The first publication, which focuses on centralized monitoring, describes how companies can use a combination of central, off-site and on-site monitoring to increase efficiencies, enhance patient safety and data integrity while maintaining adherence to good clinical practice (GCP).
The article offers examples of how TransCelerate member companies are deploying risk-based and centralized monitoring as part of a larger effort to “develop an alternative monitoring paradigm.”
To build an effective central monitoring plan, TransCelerate lays out multiple steps. “The first step is to decide whether the central monitor role is one that is a dedicated role or whether it reflects a collection of tasks that can be assigned to different roles. The second step involves a decision on whether to internally or externally source the model,” the industry group says.
And centralized monitoring should specifically involve a central review of “all data for a trial (ideally including both clinical data and operational data) to find outliers and trends and poor-performing sites,” and uses “analytics/ visualizations to evaluate risk indicators/thresholds and triggers relevant activities.”
TransCelerate also recommends companies use risk indicators that can be applicable across multiple therapeutic areas or specific to a protocol or therapeutic area.
Risk indicators “have the potential to create noise if there is too much information, while too few may prevent identification of issues that direct appropriate actions and escalations.” The paper offers several examples of workflows depicting centralized monitoring models to give companies some ideas for how to assess the workflow.
Technology
In its second paper, TransCelerate focuses on the technology considerations necessary for effective RBM.
“The right technology is critical to collect and aggregate data, provide analytical capabilities, and track issues to demonstrate that a thorough quality management framework is in place,” TransCelerate says.
Simple data capture and presentation were initially thought to be sufficient to identify risk factors, capture and compare data and allow their presentation. However, TransCelerate notes the challenges to such a simplistic view, including the likelihood that companies have data stored in a number of locations, and that risk indicators can carry different weighting.
“Inclusion of tools to enable risk assessment—such as the risk assessment categorization tool, identification of critical data and processes, and creation of monitoring and quality management plans that manage identified risks—has clear benefits in this process,” TransCelerate says.
The industry group goes on to outline what would be included in an ideal technology solution, which it says should be able to:
- Identify trends, patterns and outliers to gauge performance at the protocol, program, country, and/or site level;
- Track issue management, including identification, escalation and resolution at the various levels;
- Recommend mitigation efforts based on the TransCelerate methodology;
- Proactively produce alerts when risk indicator values meet predetermined thresholds; and
- A whole host of other capabilities from data sourcing, reporting and visualization requirements, data sourcing and aggregation.
“If you’re a fan of integration layer software, you’re well aware that the user interface is the proverbial tip of the ice burg in a complex system,” Polaris consultants say on the technology paper. “RBM solutions collect and aggregate data from many types of systems... The data in these systems have different formats and different standards, and some data, like ePRO, aren’t structured at all. TransCelerate’s paper provides recommendations to deal with these complexities.”