{"id":59161,"date":"2021-07-06T21:56:12","date_gmt":"2021-07-06T19:56:12","guid":{"rendered":"http:\/\/www.veeva.com\/eu\/?p=59161"},"modified":"2022-12-01T16:07:26","modified_gmt":"2022-12-01T15:07:26","slug":"cutting-through-the-noise-with-predictive-pharmacovigilance","status":"publish","type":"post","link":"https:\/\/www.veeva.com\/eu\/blog\/cutting-through-the-noise-with-predictive-pharmacovigilance\/","title":{"rendered":"Cutting Through the Noise With Predictive Pharmacovigilance"},"content":{"rendered":"

The impact from adverse drug reactions1<\/small><\/sup> costs the U.S. roughly $30 billion each year, affecting not only patients and their physicians, but the industry\u2019s image.<\/p>\n

Imagine if some of the drug recalls of the past could have been prevented. What if potential adverse events hidden in messages on patient-centered web sites or medical records could be brought to light and correlated with other data earlier in the drug\u2019s life cycle? All too often, these signals only emerge after the drug has been commercialized.<\/p>\n

Identifying safety signals earlier requires moving from reactive to proactive and predictive approaches to pharmacovigilance. Manual and paper-based processes will need to be automated. Safety data, siloed at many companies in different databases, must be accessible across multiple departments or functions. With more relevant data, predictive methods can better identify safety trends in a rising tide of online data. <\/p>\n

Reducing manual tasks, connecting data, and cutting through online noise<\/strong>
\nFor most companies, the first step toward proactive pharmacovigilance is reducing the number of error-prone administrative tasks assigned to pharmacovigilance teams. With a growing number of adverse events and sources of safety data, the workload for pharmacovigilance teams has increased sharply over the past decade. In 2017, one study found<\/a> 2<\/small><\/sup>, the typical large biotech company\u2019s pharmacovigilance team handled more than 200,000 individual case safety reports (ICSRs), up significantly from the 84,960 that were processed in 2007.<\/p>\n

Also crucial is connecting data points that, when considered together, can improve determination of a drug\u2019s benefit-risk profile. At many companies today, these types of data are often stored in different functional silos. Modern solutions allow pharmacovigilance teams to access, connect, and make decisions based on relevant information, wherever it is stored, in a timely manner.<\/p>\n

Companies also need to discern safety trends from a massive, and growing, number of external sources \u2014 not only global regulatory databases, but patient sites. More adverse event data is now publicly available, but a lot of cost and effort is required to cut through the complexity and noise. <\/p>\n

Outsourcing and leveraging analytics, artificial intelligence, and the cloud <\/strong>
\nThat\u2019s why a growing number of companies are making use of platforms that seamlessly aggregate and organize data for analysis, incorporating data analytics, artificial intelligence, and cloud-based data to automate pharmacovigilance processes. These tools allow teams to identify signals earlier, before they can potentially morph into blindsiding safety events\u2014and they\u2019ve also helped streamline key processes. Companies are automating the more redundant repeatable activities so they can focus skilled resources on high-value activities. <\/p>\n

Outsourcing more pharmacovigilance functions is also gaining traction. The externalization trend began with low-risk transactional functions and now more companies are moving toward an end-to-end approach<\/a>3<\/small><\/sup>. According to Global Market Insights<\/a>4<\/small><\/sup>, industry demand for pharmacovigilance outsourcing, worth more than $3.8 billion in 2019, is expected to grow by 15.8% per year over the next five years, reaching $10.6 billion by 2025.<\/p>\n

With cloud-based platforms, CROs and their pharma clients can easily and securely communicate and transfer data between teams. Web-based services permit easier access and use of data between pharmacovigilance and other functional areas such as regulatory, quality, clinical, and medical affairs. They also provide greater transparency between biotechs \/ pharmaceutical companies and their CRO partners, allowing for real-time decision-making.<\/p>\n

Emphasizing ease of use, cloud platforms often feature interactive dashboards and reports, automated and intelligent processes, and visible notifications. They can streamline the electronic submission of ICSRs to regulatory authorities and help with overall workflow, including routing, escalation, and tracking the completion of specific tasks by individuals or groups. Many modern platforms incorporate natural language processing (NLP) and machine learning to enable automatic case intake and reduce coding inconsistencies and errors.<\/p>\n

Flexibility and interoperability are key<\/strong>
\nAs the pharmacovigilance model evolves, flexibility has become key. Companies need tools that can integrate different data and automate processes without having to invest in customized and complex solutions. This is particularly true for CROs, which must accommodate a variety of customers and types of therapies as they assume a more visible role in the pharmacovigilance industry<\/a>5<\/small><\/sup>.<\/p>\n

A number of CROs have introduced modern pharmacovigilance programs including digitalized processes and intake forms, NLP, mobile, and native cloud-based technologies. 6,7<\/small><\/sup><\/p>\n

Greater transparency on the cloud<\/strong>
\nFor Ivan Mihalic, pharmacovigilance IT systems manager at the pharmacovigilance services provider Arriello, Veeva Vault Safety<\/a> offers powerful functionality yet is flexible for customization. The system takes a short time to implement, he said, and enables fast onboarding of new clients. <\/p>\n

Jennifer Kratz, director of safety services at Clinlogix, a growing midsized CRO, switched to Vault Safety as there was a mismatch between the company\u2019s needs and the previous pharmacovigilance platform, which was more tailored for large pharma companies. The software was difficult to set up, upgrade, and modify to meet client-specific workflows, while licensing costs were high, Kratz said.<\/p>\n

At the same time, the previous pharmacovigilance solution was fragmented. Clinlogix had to buy additional software adding to the complexity. \u201cWe needed a modern, intuitive application that would make it easy to administer, train, access data, and generate reports for clients,\u201d Kratz said. Clinlogix users reported a much better experience with Vault Safety. \u201cNow, we can align better with our customers,\u201d she added. <\/p>\n

As companies evolve their pharmacovigilance operations, cloud-based safety systems offer greater flexibility, and stay aligned with changing business requirements while reducing validation and resource overhead. They also enable greater transparency and data access for both biotech \/ pharma companies and their partners, to support better decision-making and more proactive pharmacovigilance. <\/p>\n

The drug industry is conservative about embracing new technology. Predictive pharmacovigilance tools are still under development and their routine use may be several years off. For now, adoption of better data access and management, and more proactive practices, is helping more companies improve patient safety and reduce risk.<\/p>\n

To learn more about simplifying your safety reporting, watch the webinar, \u201cBuilding a Foundation for Predictive and Proactive Pharmacovigilance<\/a>.\u201d<\/p>\n

\nReferences<\/strong><\/p>\n

1<\/small><\/sup> J. Sultana, Pl Cutroneo et al, \u201cClinical and Economic Burden of Adverse Drug Reactions,\u201dJ Pharmacol Pharmacother. 12(4)(Suppl1): S73\u2013S77, 2013. https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3853675\/<\/a><\/small>
\n2<\/small><\/sup> S. Stergiopoulos, M. Fehrle, et al, \u201cAdverse Drug Reaction Case Study Practices in Large Biopharmaceutical Organizations from 2007 to 2017,\u201d Pharmaceut. Med 33(6) 499-510 (2019). https:\/\/pubmed.ncbi.nlm.nih.gov\/31933240\/<\/a><\/small>
\n3<\/small><\/sup> Bioclinica White Paper, “The Future for Pharmacovigilance is End-to-End Outsourcing,<\/a>” Informa Pharma Intelligence\/Pink Sheet, June 2020.<\/small>
\n4<\/small><\/sup> Global Market Insights, \u201cPharmacovigilance Outsourcing Market Share, 2026 Forecast,<\/a>” grminsights.com, December, 2019.<\/small>
\n5<\/small><\/sup> J. Kratz and K. Traverso, \u201cModernizing Pharmacovigilance Outsourcing,<\/a>” veeva.com, February 2, 2020. <\/small>
\n6<\/small><\/sup> H. Morse, \u201cAccelerating Drug Development Without Sacrificing Safety: How Pharmacovigilance is Keeping Pace with COVID-19 Clinical Research,<\/a>” endpts.com, June 2020.<\/small>
\n7<\/small><\/sup> PRA Health Sciences Press Release, \u201c PRA Health Sciences Expands Its Response to COVID-19 With Pharmacovigilance Solutions for Authorized Vaccines and Therapeutics,<\/a>\u201d globalnewswire.com, April 21, 2021<\/small><\/p>\n","protected":false},"excerpt":{"rendered":"

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