ArisGlobal , developer of the LifeSphere ® technology platform and a leader in global patient treatment solutions, has announced impressive new study results demonstrating the effectiveness of Proactive Safety Signal Detection in improving patient safety confirm. In particular, the results support the technology’s ability to distill precise and meaningful drug event insights directly and efficiently from real-world data, thereby increasing drug safety – and potentially supporting new indications.
A baseline and comparative study of ArisGlobal’s LifeSphere ® Proactive Signal Detection technology was based on 12 years of Individual Case Safety Reports (ICSRs) (over 6 million, from Vigibase) and EMR and damage reports (18,000, c/o Patient Lives).
The results showed:
- 42% fewer false positives;
- 19% more “real” signals and
- a 39% improvement in signal optimization.
The basic study tested whether it is possible to generate a signal power that directly correlates with the probability of a drug-event combination (DEC) becoming a validated signal and how well an undesirable one Event (Adverse Event – AE) can be detected in real data.
The comparative study then examined the extent to which false positive results can be reduced compared to conventional methods (precision rate) and the extent to which the Proactive Signal Detection method successfully detects real signals (the recall rate).
Applied to real patient data from sources such as electronic medical records (EMRs) and claims reports, Proactive Signal Detection technology enables efficient and effective monitoring and assessment of drug events, without delay and without the need to engage data scientists. This could transform the monitoring of adverse drug reactions, increasing patient safety while enabling new, benefit-based discoveries that expand a drug’s target market.
Elizabeth Smalley , Director of Product Management for Data & Analytics at ArisGlobal, spoke about the importance of proactive signal detection at the recent EU and US World Drug Safety Congress 2023 events. She also cited the study results in her recent webinar, What Leading Firms Are Prioritizing in Safety Case Reporting and Signal Analytics
She commented: “Our innovative and proven Proactive Signal Detection technology will revolutionize pharmacovigilance (PV) and have a direct impact on patient safety and a drug’s addressable market.
“Signal detection in real-world drug monitoring has changed little since the practice was introduced in response to the thalidomide tragedy in the late 1950s and early 1960s,” she explained. “But now intelligent analytics, applied to robust real-world data, “Comprehensive, proactive signal detection becomes a reliable reality. The breakthrough could also help identify new opportunities for drug repurposing so that safety not only protects patients, but also provides economic benefit.”
ArisGlobal’s patent-pending technology, which will be integrated into ArisGlobal’s LifeSphere ecosystem for patient treatment development, performs causal and sensitivity analysis to significantly reduce signal “noise.” The technology is another strong addition to the robust and comprehensive LifeSphere ecosystem and a key offering within the company’s data and analytics product line.
In a 2022 ArisGlobal report on the life sciences industry, 70% of biopharmaceutical industry professionals stated that the efficiency of safety signal analysis is not yet mature.
Outside the clinical setting, with its inherent limitations, adverse event monitoring relies too heavily on patient and clinician reports. And even, too many adverse events go unreported (up to 95% in the worst cases). Proactive signal detection, based on a broad pool of standardized real-world data, closes this gap.
Mike Gordon , CEO of ArisGlobal , commented: “Proactive signal detection that leverages real-world data will transform patient safety while overcoming many of the frustrations drug manufacturers, regulators and clinicians experience in post-market drug monitoring.” He continues: “We “We are pleased and proud to lead the market with groundbreaking technology that will have a transformative impact on our customers and the industry, ultimately leading to more safe and effective treatments getting into the hands of doctors and patients sooner.”
SOURCE: PRNewswire
