Passive drug safety surveillance can miss important connections between drugs and outcomes.
It’s time to get more active around safety surveillance.
Active drug safety surveillance has been a hot topic for some time, especially since the FDA Sentinel System moved out of its pilot phase in 2016.
Established by the FDA Amendments Act of 2007, the Sentinel Initiative aims to glean intelligence from real-world data and use it to identify correlations between therapeutics and adverse outcomes.
In a recent webinar we held on the topic of active safety analytics, Dr. Judith Maro of the Sentinel Operational Center explained that one of the catalysts for Sentinel was the link between the drug Vioxx and myocardial infarction. Traditional passive surveillance methods—direct reporting from healthcare professionals, patients, and caregivers—failed to detect the connection for a long time, mainly because heart attacks weren’t known or believed to be drug induced.
Once the connection was made, it became obvious that more active measures needed to be taken to ensure patient safety with marketed medical products. Thus the Sentinel system, and the Active Risk Identification and Analysis (ARIA) system within it, were born.
The Sentinel contract was reapproved in 2019 and two new Centers were created, one for community building and outreach and another for innovation. The Innovation Center is currently focusing on the application of AI technologies like natural language processing and machine learning to analyze unstructured clinical text in EMR notes.
What Can Active Surveillance Tell You?
The ARIA system within Sentinel enables the FDA to proactively identify signals using real-world data, and further carry out signal evaluation through Level 1, 2, and 3 analyses that investigate causal inference for specific drug/outcome pairs. The FDA further encouraged the development of TreeScan methodology for signal detection.
At the point of approval, the FDA may require certain drugs to undergo safety monitoring after they enter the marketplace. If the FDA determines that passive surveillance and Sentinel/ARIA are sufficient to monitor any suspected safety issues, the FDA will manage the safety monitoring itself. If not, the FDA can require a sponsor to conduct a post-authorization clinical trial or observational study.
A Gateway to the Sentinel System
Dr. Carla Rodriguez-Watson, IMEDS Scientific Director at the Reagan-Udall Foundation for the FDA and another webinar panelist, explained how the Foundation advances the FDA’s mission by providing access to the Sentinel system. “If the onus is put on the sponsor, [we can help them] create everything from protocol to statistical analysis plans through monitoring studies, feasibility assessment, and signal evaluation in these comparative studies…using the same tools as Sentinel, really leveraging that infrastructure and that resource.”
ASAP—Saama Puts the Power of Sentinel in Your Own Hands
Beyond ad hoc studies for evaluating specific drug-outcome pairs, life sciences companies see a need for incorporating the use of real-world data into their routine safety surveillance processes.
In collaboration with Gilead Sciences, Saama has developed a new solution—Active Safety Analytics for Pharma (ASAP)—that can help pharmacovigilance, epidemiology, and medical affairs teams identify, investigate, and respond to signals in order to ensure greater patient safety.
Using third-party claims and EMR data, ASAP provides all the data modeling, analytics and workflows needed to make it easy for safety analysts to navigate the post-authorization safety surveillance framework and answer FDA questions.
“ASAP complements the whole process of passive surveillance,” says Ram Keshavamurthy, Sr. Director of Life Sciences Solutions at Saama. “Using longitudinal data from 150 million patients over the past 15 years, sponsors can conduct safety surveillance in a much more organized fashion.”
In the webinar, Ram explains how ASAP facilitates signal validation through a robust workflow for assessment, medical review, and approval of safety signals. “The safety analyst [can] dig deeper, beyond the Multi-level Clinical Classification System Level 4 nodes, look at the ICD categories that were involved, and even go to the level of patients with ease….We’re talking about billions of records of outcomes that are out there and allowing the analyst to go to the particular signal and … patient-level information to further assess whether it’s a true signal or not.”
For more information about how ASAP puts the power of active safety surveillance in the hands of your pharmacovigilance, epidemiology, and medical affairs teams, contact Saama today. We’d be happy to walk you through a demo of our groundbreaking solution.