Jean Redmond, PhD- COO, Biologit
Medical literature monitoring is a key part of pharmacovigilance (PV) and ultimately patient safety across the lifecycle of a medicine. Globally, the practice is relatively straightforward, but up to now, screening local literature has been a highly resource-intensive activity yielding modest, if vital, findings. That smart automation might alleviate the burden comes as a huge relief, especially as product development ambitions grow and PV process innovation becomes essential to control costs. Biologit’s Jean Redmond explains.
Adverse events from medications are common, affecting patients and healthcare systems worldwide. Pharmacovigilance (PV) - the monitoring and prevention of adverse drug events - is essential to patient safety across a medication’s lifecycle. Medical literature monitoring - the systematic review of published reports of adverse events - is a key part of this activity.
Globally, the practice is relatively straightforward - drawing on well-known, indexed journals via large databases. But screening local literature (critical for identifying adverse events relevant to specific countries or populations) is comparably inefficient and error-prone. It involves the manual tracking of region-specific sources, including non-indexed journals and local publications. This resource-intensive activity is often outsourced, yet without efficient and reliable processes, costs can run high and returns can seem low.
The Local Monitoring Imperative
Up to now, the pain of local literature monitoring has been an accepted frustration. This is an activity that cannot be skimped on, after all. Local literature monitoring is the only way to ensure that adverse drug reactions and safety signals published in regional or country-specific journals are identified and reported. These sources often contain critical safety data that may not appear in global databases.
Comprehensive local literature monitoring is generally expected, if not mandated by health authorities, as part of PV reporting. It completes the global picture, and is a way of identifying population-specific adverse events – important trends which otherwise might be missed. Local sources, including journals, websites, or print sources, provide crucial insights at the country level. If gaps in routine monitoring are discovered during inspections or audits, this could have implications for ongoing licensing and sales, as well as brand reputation.
Strategically, local insights enable better decision-making, allowing pharmaceutical companies as well as healthcare systems to respond proactively to emerging safety concerns and adapt labelling or guidance at a country level. By extension, discrete local findings can also serve as an early warning system and provide insights for ongoing product development.
Frustratingly, however, while traditional approaches to local literature monitoring might deliver relevant findings, they do so at immense cost and manual burden.
How Existing Approaches Fall Short
In spite of its critical importance, local literature monitoring is still highly inefficient when the activity is carried out in the traditional manual way. The screening process is time-consuming, often requiring dedicated staff at an affiliate or regional level, potentially with local language capabilities and journal access. In addition, despite the large volume of data being reviewed, local monitoring typically yields only limited safety information. Errors and omissions are common.
Because of its intense administration burden, local literature monitoring is usually outsourced to a clinical research organization to alleviate the drain on internal PV experts. Usually, the numerous designated sources are listed in multiple, long, and unwieldy Excel spreadsheets, with assigned teams expected to monitor several thousand different websites on a weekly or monthly basis. Each row in each spreadsheet contains a web link that needs to be searched, the results then captured and populated in the same Excel file. At the end of each cycle, all of the disparate Excel files are aggregated and distributed as needed.
The problem is compounded by huge variances in the literature format, literature access issues, and language barriers. Local sources often lack consistency in format, indexing, and language, making it difficult to implement a simple unified process; meanwhile, many local journals require paid subscriptions or may be only available in print.
While traditional approaches to local literature monitoring might deliver relevant findings, they do so at immense cost and manual burden.
On top of this, regulatory reporting timelines vary by country, something else that has had to be tracked manually to ensure respective adherence. In the EU and Australia, MAHs are expected to conduct a literature review at least once a week. Within Europe, individual countries have differing expectations. Some EU competent authorities have a required list of local sources to be reviewed; others have recommended lists; and others don’t (yet) specify which sources should be monitored.
Automating the Unmanageable: A Data/Tech Breakthrough
All of these challenges present a regulatory risk, and a risk to patient safety, because of the potential to miss safety events, in addition to carrying a costly administrative burden for companies. With the growing focus on specialty drugs including more personalized and targeted treatments in oncology and for rare disease, including new therapeutics such as CAR T-cell therapies, strong drug safety/PV oversight is essential, not least linked to new mechanisms of action. Many regulators are striving to accelerate access to important new drugs too, making real-world monitoring even more crucial.
It is for all of these reasons that the pharma industry and its service provider community are looking to next generations of automation technology for an answer, both to improved cost-efficiency in local literature monitoring and to increased accuracy and reliability.
Processes powered by advanced technology, including large language models (LLMs), are proving instrumental in structuring data, for instance - enabling “normalization”, unification, centralized management, and governance, as pharma transitions to “data-first” ways of working. In addition to improved data structuring, advanced “crawling” techniques are transforming automated browsing, “scraping”, and indexing of content from target web sites and publications. AI then adds a layer on top of that, making it possible to search all of that content and very quickly and identify safety events, in one fell swoop, via a single unified database.
Thresholds for Advanced Technology Use – And The Risk Of Inertia
There is a “horses for courses” element to all of this. For a small company that wants to search just three countries, with perhaps up to 10 journals in each, manual searches are unlikely to be onerous. But once that burden multiplies, to become hundreds or thousands of sources which need to be reviewed weekly or monthly, the workload soon becomes untenable without the help of robust automation to ensure cost-efficiency, speed, and accuracy – as well as instant reporting.
Technology is evolving in leaps and bounds, but where patient safety is concerned there will always be an important role for human oversight and process governance. Technology-assisted human ingestion is another option, where companies are more hesitant about immediate technology reliance. But persisting without automation is hard to justify now.
Most pharma companies have come to recognize that, unless they buy into technology-enabled process innovation, they will struggle to keep pace with the competition, and with soaring operational costs in a challenging market. Even regulators accept this, and are becoming increasingly open to automation as a means of improving compliance and patient outcomes.
Certainly, PV workloads are not diminishing and PV scientists are already overstretched and keen to have more time to performing actual safety assessments – instead of searching web sites, performing manual data entry tasks, and trying to decipher messy spreadsheets. With easy, rapid access to the data they need, they could skip to the more fulfilling and higher-value activities that form the core of their role. Automation further enables PV scientists to better manage the ever-growing workload associated with the increase in publications year on year.
Maintaining Purpose
Finally, but crucially, this isn’t about adopting technology for its own sake because of a performance promise. Companies looking for an advantage through automation in local literature monitoring must do so in the context of this being a regulated activity. That is, process innovation should be introduced in a balanced way that will not compromise delivery timelines, future audits, or other fundamental requirements.
Looking ahead, as companies do transition away from laborious manual processes in all aspects of their literature monitoring, the strategic potential lies in the new, richer, data-driven insights they will gain about safety trends. Ultimately, this is an opportunity for companies to better understand the safety trends around their drugs, and at a more discrete level. The value of having earlier visibility into trends in different patient populations, in different countries and regions, will soon become apparent. As well as informing ongoing drug discovery and development, these insights could also inform the respective healthcare system, and patient journey, in a given region, with wider societal benefits.
This will be thanks to the ability to hone searches, and more efficiently identify true safety events –by scouring the largest volume of information possible to confidently arrive at the smallest number of safety events for review, knowing that nothing has slipped under the radar.
Jean Redmond, PhD, is COO at Biologit. She is a scientist with 10+ years’ experience in consulting, strategy and general management gained by working with multiple life science offerings and teams at a global clinical research organization. Biologit is a specialist in advanced, technology-enabled safety surveillance solutions for life sciences.
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