P205: Early Severe Adverse Event Warning Mechanism
Poster Presenter
Sahith Doppalapudi
Associate Director, PV Analytics Analytics Center of Excellence
Bristol Myers Squibb United States
Objectives
This initiative aimed to provide an early warning mechanism for severe adverse events in clinical trials, enabling the Clinical Safety Monitoring teams to review serious adverse events/ events of interest in real-time, and perform prompt actions for continuing, delaying, or discontinuing treatment.
Method
This process involved identifying the data entry fields for review and determining the feasibility of sharing this information with the appropriate trial-specific teams, using the existing ecosystem and minimizing human intervention. Simultaneously, the scalability of the solution was also assessed
Results
An alert system was meticulously established to ensure that key personnel, including the Global Trial Manager, Clinical Scientist, and Pharmacovigilance Scientists, receive critical information at a minimum. The alert template was carefully crafted to include essential fields such as the study number, site number, subject number, country, verbatim description of the event, coded event, and a detailed narrative. These fields were chosen to provide a comprehensive overview of the situation, enabling informed decision-making.
The process was designed to ensure that this crucial information was promptly sent out as soon as the medical reviewer completed the case information. This immediate dissemination of data was intended to minimize delays and ensure that the relevant teams could act swiftly.
Upon receiving the alert, the corresponding teams, including the Global Trial Manager, Clinical Scientist, and Pharmacovigilance Scientists, began a thorough review of the provided details. This initial review was critical in understanding the context and severity of the adverse event. The teams then proactively reached out to the relevant sites to gather additional information. This step was essential to gain a deeper understanding of the causal relationship between the drug and the adverse event. By engaging directly with the sites, the teams could obtain firsthand information and clarify any ambiguities.
Based on the comprehensive information gathered, the teams conducted a detailed assessment to determine the appropriate course of action. This assessment involved evaluating whether to continue, delay, or discontinue the treatment for the patient. The decision-making process was guided by the primary objective of ensuring patient safety while maintaining the integrity of the clinical trial.
Conclusion
This innovative solution brought about a significant improvement in operational efficiency by drastically reducing the time required to share case details with the clinical team. Previously, this process could take several days, but with the new system in place, the time has been cut down by an impressive 3 to 5 days.
The solution has greatly enhanced collaboration between the clinical and safety teams. By streamlining communication and data sharing, it has fostered a more integrated and cohesive working environment. One of the key benefits is the elimination of the need for read-only access to the safety database. This change not only simplifies the process but also enhances data security and integrity by reducing the number of individuals who need direct access to sensitive information.
In addition to improving collaboration, the solution has also alleviated the burden on case processing teams. Previously, these teams were frequently tasked with generating and sharing reports ( 50-60/month), which was a time-consuming and repetitive process. The new system has significantly reduced this workload by automating many of these tasks and incorporating narratives directly into alerts. This means that the need to generate frequent CIOMS (Council for International Organizations of Medical Sciences) reports has been eliminated, freeing up valuable time and resources for other critical activities.
The framework of this solution is designed to be highly scalable, making it adaptable to the needs of a growing number of studies. Currently, alerts have been set up for over 60 active studies, demonstrating the system's capacity to handle a large volume of data and its potential for future expansion.
Overall, this solution has improved efficiency, enhancing collaboration, reducing the need for direct database access, and minimizing the burden of report generation, it has created a more streamlined and effective workflow that benefits all parties involved.
