Facing ever-increasing costs of running a clinical trial, sponsors must ensure they are properly directing their budget and resolving the areas of highest risk while maintaining patient safety and data integrity.
How can sponsors implement a robust process to allow earlier identification of emerging risks during the course of a trial? This article covers five tips for defining risk levels, categorizing risk and maintaining oversight to ensure that risks and responses are appropriately identified, documented, tracked and managed throughout the life cycle of a study.
1 – Defining your levels of risk
Risk is a natural occurrence in any trial that takes place at the program, study level, site level and operational level. Defining it is the first step to gaining control. At a high level, the overall risk of a study can be evaluated. For example, a Phase II oncology study would indicate a higher risk that requires a more stringent monitoring strategy as compared to a low-risk Phase IV observational study.
Study risks can also vary based on known, high-performing sites versus new sites with less familiarity to the therapeutic area. Finally, operational risk can be estimated based on real-time patient enrollment data to compare actual performance to the forecast.
2 – Assessing and categorizing risk
With the defined levels of risk at the study, site and operational levels, an overall risk assessment can be created for a protocol and across a program. We use Xcellerate® Monitoring, a solution with standalone SaaS capability to oversee a robust risk management process.
One module of the platform, the Risk Assessment Categorization Tool, applies an algorithm to create an overall category score based on the probability, impact and detectability of the risks, allowing sponsors to make data-driven decision about the most appropriate intervention levels.
3 – Focusing on key areas of risk
After risks are categorized, they can also be filtered through the user interface of Xcellerate Monitoring to highlight those with the greatest impact on a study, enabling sponsors to appropriately redirect resources. With Xcellerate Risk and Issue Management all members of the study team are able to create, view and manage issues in real time from a single interface.
For example, if the system identifies key risks as excessive underreporting and patient retention, the sponsor and CRO can work together to ensure they are monitoring and controlling these areas throughout the life of the study. This process enables early implementation of preventive actions and can help minimize quality failures.
4 – Monitoring and controlling risks
Even with risks defined and categorized, it’s essential to monitor the status of the risks throughout the life of a study. We leverage Xcellerate Risk Review to aggregate electronic data and trigger early detection and actions.
With automatic metrics, the system generates recommendations to increase, decrease or maintain monitoring levels at a site using key risk indicator scoring. This helps the trial’s project team to take action and allows sponsors and CROs to prioritize and target individual sites. The automated process also helps manage escalation paths and fulfills regulatory guidance surrounding adapted and triggered site monitoring.
5 – Evaluating the effectiveness of risk management
As risks are identified, categorized and managed over time, sponsors and their supporting CRO can view the cumulative actions taken month over month, assessing their level of effectiveness and determining if the activities performed helped bring a site back to a lower risk level.
Ideally, sponsors should see that over time, a greater proportion of sites are moving into the standard and low-risk categories, with an overall decrease of the sites in the high-risk categories. This level of transparency not only helps with continuous improvement practices but also demonstrates a full level of control and compliance to regulatory agencies.
Creating a comprehensive strategy for risk
With today’s large global trials and virtual project teams using multiple systems acting in isolation, sponsors need an effective method to accelerate decision making and close the gaps in trial oversight. Unifying quality and risk management across a single study or a portfolio of studies helps revealing signals before they become systemic issues that derail a trial.
Xcellerate Monitoring unites disparate systems, offering unprecedented access to all clinical trial data and platform connectivity. Learn more about how we can ensure frictionless execution of our clinical studies to effectively adhere to quality management requirements in your clinical studies.