Need a refresher on what risk-based monitoring is? Check out this previous blog.
Risk-based monitoring (RBM) signifies a shift away from analyzing every piece of data from a trial in hindsight to a more focused analysis that happens in real-time. The clinical trial landscape, data requirements, and patient trends are always changing. RBM requires a technology platform that can future-proof against the challenges of a continuously changing clinical research landscape, provide the ability to capture critical pieces of data, and look holistically across a study for trends and issues. This is no simple task.
Choosing the correct technology to support your RBM strategy is critical to success. Here, we discuss five essentials to consider:
1. DATA-AGNOSTIC INTEGRATION
Modern outsourcing approaches for trial conduct typically result in increased numbers of data sources and disparate systems being used to collect clinical trial data. Your RBM platform needs to be data-agnostic so you can accelerate the acquisition of data from any application, database, or report, and fully integrate diverse data sources to generate simple and actionable analytics in real-time. Make sure to look for a platform that continuously assimilates data from multiple sources and has powerful data visualization capabilities. This is the only way to genuinely achieve timely risk management and effective RBM across all of the participating sites.
2. A USER-FRIENDLY INTERFACE
A clear and simple dashboard that equips users with crucial intelligence in a digestible format so they can spot problems early and take action is key. Clear and easy-to-use data visualization needs to be combined with rapid access to the data underneath to allow study teams to explore data in detail down to the levels of performance by site or country – and to create bespoke reports. Make sure the platform you select uses clear and consistent navigation routes that are easily recognizable to users.
3. INTELLIGENT MONITORING
Part of the power of RBM is enabling sponsors and CROs to move to more intelligent monitoring methods so you can direct resources to monitoring the sites or subjects who are at the greatest risk. Make sure the technology platform you select supports intelligent monitoring with real-time visualization and flags of trial-level issues like recruitment delays or protocol deviations. Early oversight of risk empowers you to quickly identify problems and roll out prompt interventions, like protocol amendments.
4. TRACKING ACTIONS IN REAL-TIME
Your RBM platform should include clear action and escalation workflows triggered by different risk scores and allow the user to track actions as they happen, providing an instant audit trail for regulators. Ideally, this should extend to the ability to distribute tracked communications, documents, and trial alerts, and include functionality to allow study managers to see whether critical study communications have been received, read, and noted.
5. ADAPTABILITY & TRAINING CAPABILITIES
Finally, look for a platform with a degree of inbuilt flexibility. Risks may change during the study and sponsors are encouraged by regulators to adopt a flexible approach to RBM. Your supporting technology platform must be adaptable and allow for a mix of standard key risk/performance indicators and the ability to change during the course of the trial. This includes the ability to roll out targeted training at the start of the study, and on an ongoing basis as needed, to address issues arising across the trial and to mitigate risk.
Remember the FDA’s Guidance for Industry document titled ‘Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring’, which tells us that: “without meaningful training prior to the conduct of a study and of appropriate instruction during the study (e.g., when changes are made to the protocol), coordinating investigators and their staff may have difficulty carrying out a trial correctly. Sponsors who plan less frequent or limited on-site monitoring should consider the following:
- It may be necessary to implement alternative training (e.g., teleconferences, webcasts, online training modules) and communication methods (see section III .B.1) for providing and documenting ongoing, timely training and feedback, as well as to provide notification of significant changes to study conduct or other important information.”
In summary, look out for these five key features when selecting an RBM platform for your trial:
- Data-agnostic integration
- A user-friendly interface
- Intelligent monitoring
- Tracking actions in real-time
- Adaptability & training capabilities