The Strategic Imperative to Solve the Local Literature Monitoring Problem
Nicole Baker, CEO & Co-Founder, Biologit
Traditional in-country literature screening involves manually tracking nonindexed journals and local publications. But now tech-powered processes are helping to structure and ‘normalise’ data; new ‘crawling’ techniques are transforming automated browsing, ‘scraping’, and indexing of target content, with the option to engage AI to identify all relevant safety events on demand.
The monitoring and prevention of adverse drug events, which forms the core of Pharmacovigilance (PV), is critical to ensure patient safety across a medication’s lifecycle.
A key part of this practice is medical literature monitoring; the systematic review of published reports of adverse events. Globally, this activity is fairly straightforward, extracting from highprofile, indexed journals logged in large databases.
By contrast, screening local (in-country) literature — critical for identifying adverse events relevant to specific countries or populations — is traditionally highly resource-intensive, yet unreliable in its performance and its return on investment. Often outsourced, the process involves manually tracking region specific sources, including non-indexed journals and local publications.
What is the urgency around local literature monitoring?
To date local literature monitoring has been seen as a necessary evil, with no easy shortcuts. It is expected or mandated by many health authorities. That’s because it is the only sure bet to establish that adverse drug reactions and safety signals published in regional or country-specific journals, web sites and/or print sources, are identified and reported. These insights may not surface via global databases.
Local literature monitoring is also a way of identifying population-specific adverse events that might otherwise be missed. If gaps in routine monitoring are discovered during inspections or audits, this could have implications for ongoing licensing and sales, not to mention market confidence.
At a strategic level, local insights enable better decision-making. They allow pharmaceutical companies, as well as healthcare systems, to respond proactively to emerging safety concerns, and adapt labelling or guidance at a country level, as needed. By extension, discrete local findings can also serve as an early warning system, and provide insights for ongoing product development.
What is at the heart of current challenges?
Despite its critical importance, local literature monitoring remains highly inefficient when performed in the traditional, manual way. It typically requires dedicated staff at an affiliate or regional level, often with local language capabilities as well as local journal access. The payback can seem limited though: irrespective of the scale of data being reviewed, local monitoring typically yields only limited safety information; errors and omissions are commonplace too.
Commonly, in an attempt to derive maximum cost-efficiency from the practice, local literature monitoring is outsourced to clinical research organisations, reducing the strain on in-house PV scientists. The process generally involves a diverse range of designated sources, listed in multiple, long, and unwieldy Excel spreadsheets. Ultimately, assigned teams are expected to monitor several thousand different web sites on a weekly or monthly basis.
Each row in each spreadsheet contains a web link which needs to be searched, the results then captured and populated in the same MS Excel file. At the end of each cycle, all of the disparate Excel files are aggregated and distributed as specified.
The challenge is compounded by substantial variances in the literature format, literature access issues and language barriers. Local sources generally 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.
Additionally, regulatory reporting timelines tend to 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 tracked.
How data rigour and tech advances are offering to transform the process
All of these challenges above present a regulatory risk, as well as a risk to patient safety. This is due to the potential to miss safety events, not to mention the costly administrative burden for companies.
It is a situation that will only intensify, too. With the growing focus on specialty drugs including more personalised 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 “normalisation”, 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 very quickly and identify safety events, in one fell swoop, via a single unified database.
Balancing technology potential with human oversight for essential governance
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 recognise 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 on having more time to perform 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.
Seeing a bigger picture that extends beyond PV
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.
Author Bio
Nicole Baker, PhD, is CEO and Co-Founder of Biologit. She is an Immunologist and Pharmacovigilance Professional, with a strong focus on innovation in Medical Affairs, Regulatory Affairs, Pharmacovigilance and Clinical Trials, gained by leading and managing global, multi-disciplinary teams. Biologit specialises in safety surveillance innovation and transformation for life sciences.
