New Study Confirms Power of Real-World Data in Proactive Signal Detection, Improving Patient Safety

Challenging a discipline that has barely evolved in 70 years, ArisGlobal’s patent-pending Proactive Signal Detection technology demonstrates 40% greater accuracy than established detection methods

Boston, Massachusetts, USA – ArisGlobal, creator of the LifeSphere® technology platform and a market leader in global patient treatment solutions, has announced striking new study results confirming the power of Proactive Safety Signal Detection in improving patient safety. Specifically, the findings support the technology’s ability to distill precise, meaningful drug-event insights directly and efficiently from real-world data, boosting drug safety – while potentially also supporting new indications.

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A foundational and comparative study of ArisGlobal’s LifeSphere® Proactive Signal Detection technology, drew on 12 years of Individual Case Safety Reports (ICSRs) (over 6 million, from Vigibase) and EMR and claims records (18,000, c/o Patient Lives).

The findings revealed:

● 42% fewer false positives;

● 19% more ‘true’ signals; and

● a 39% improvement in signal optimization.

The foundational study tested whether it was possible to create a signal strength that will be directly correlated to the likelihood that a drug-event combination (DEC) would become a validated signal, and how well an adverse event (AE) could be detected in real-world data.

The comparative study then looked at the capacity to reduce false positives, compared to traditional methods (the precision rate); and to what extent the Proactive Signal Detection method successfully captured true signals (the recall rate).

Applied to real-world patient data from sources including electronic medical records (EMRs) and claims, Proactive Signal Detection technology makes it possible to monitor and assess drug-events efficiently and effectively, without delay and without the need to consult data scientists. This could transform the surveillance of adverse drug reactions, boosting patient safety, while also enabling new benefit-based discoveries to be made - enlarging 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 findings in her recent webinar, What Leading Firms Are Prioritizing in Safety Case Reporting and Signal Analytics: (https://resources.arisglobal.com/media/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) with a direct impact on patient safety, as well as a drug’s addressable market.

“Signal detection in real-world drug monitoring has hardly changed since the practice was first introduced in response to the thalidomide tragedy of the late 1950s/early 1960s,” she explained. “But now smart analytics, applied to robust real-world data, makes comprehensive, proactive signal detection a reliable reality. The breakthrough could also help identify new opportunities for drug repurposing, so that Safety becomes a driver of commercial benefit as well as a protector of patients.”

ArisGlobal’s patent-pending technology, which will be added to ArisGlobal's LifeSphere ecosystem for patient treatment development, performs causal and sensitivity analysis to substantially 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 life sciences industry report from ArisGlobal, 70% of biopharmaceutical professionals indicated a maturity gap in the efficiency of safety signal analytics processing.

Outside of the clinical environment, with its inherent limitations, adverse event monitoring relies too heavily on patient and clinician reporting. And, still today, too many adverse events go unreported (up to 95% in the worst cases). Proactive signal detection, drawing on a broad pool of standardized real-world data, targets this gap.  

ArisGlobal’s CEO, Mike Gordon, commented, “Proactive signal detection that leverages real-world data will transform patient safety, while overcoming many of the frustrations experienced by drug companies, regulators and clinicians around post-market drug monitoring.” He continues, “We are delighted and proud to lead the market with breakthrough technology that will have a transformative impact on our customers and the industry, and ultimately lead to more safe and effective treatments being put into the hands of clinicians and patients earlier.”