Andrew Purchase, Director of Pharmacovigilance & Patient Safety and UK QPPV at ICON sat down with Vivian MacAdden, Senior Manager, Industry Marketing at DistillerSR to discuss the critical role of literature surveillance in the pharmaceutical and biotechnology industries, and how automation can support this process.
Q: Let’s start with the basics. Can you briefly explain the importance of literature surveillance and literature reviews for pharmaceutical and biotechnology companies?
A: Literature surveillance is an important tool in the suite of monitoring activities to ensure the safety of medicinal products. The success of published literature surveillance is measured by precision and sensitivity. Pharmaceutical and biotech companies must screen and analyze published literature from the clinical development stage, through post-marketing, as part of their pharmacovigilance obligations. It is critical to detect safety signals as soon as possible to affect appropriate measures and protect patient safety.
During clinical development, it is mandated that drug developers perform literature surveillance activities, such as ongoing safety evaluation or annual safety reporting (i.e. development safety update reports, or DSURs). This obligation intensifies when the developer submits a new drug application (NDA) or marketing authorization application (MAA) and receives authorization to market its product. Once that happens, it becomes a requirement to perform literature review no less than once a week. It is also expected that NDA and marketing authorization holders (MAHs) have procedures for monitoring local publications in countries where the product has been authorized for marketing.
Q: How did the COVID-19 pandemic affect literature surveillance practices?
A: The COVID-19 pandemic called for a global effort to develop safe and effective treatments/vaccines to combat the disease. We saw the timeframe for the development of such products shortened, which in turn, increased the level of scrutiny they faced. Routine literature surveillance is a mandated requirement for any newly approved medicinal product but the amount of recall when performing a search during a public health emergency is significantly increased.
In light of an ever-changing landscape, it is essential to continually monitor the effectiveness of your literature strategy and revise it frequently. You need to consider, for example, the development of vaccines, the evolution of the disease, and the available treatment options.
When performing literature surveillance under an increased level of scrutiny combined with a likelihood of a high volume of information, it is even more critical to have a robust literature review strategy and to rely on automated solutions that help you digest large volumes of evidence while streamlining your literature review completion rates.
When performing literature surveillance it is critical to have a robust literature review strategy and to rely on automated solutions that help you digest large volumes of evidence while streamlining your literature review completion rates.
Q: How do you develop an adequate literature surveillance strategy?
A: There is an incredible amount of available literature and a vast number of potential sources (e.g. Embase, PubMed, Reactions Weekly, Biosis, among others). Finding every piece of literature that may be published is challenging. Therefore, conducting a literature search requires a realistic, pragmatic, and objective approach along with targeted search strategies. Proper planning will ensure that the number of relevant search results is as precise as possible.
It is essential to develop a search strategy that is both robust and targeted. Next, you need to establish the purpose of the search. Ask yourself: what is the primary objective of the search? Are you looking for general safety information or individual case safety reports (ICSRs) to identify new information about the medicinal product, or to monitor a particular safety signal? In the clinical development setting, exposure to the medicinal product happens in a controlled environment and can be limited to a certain patient population. When the medicinal product moves to market, exposure widens to other patient populations, and new or emerging safety information may be found. It is important to evolve your search strategy based on what you learned about the medicinal product and the objective of the search.
Safety signals can arise from different data sources, including scientific literature. Scientific articles may describe case reports with the use of a medicinal product or results from studies conducted with the product in question. Monitoring the scientific literature can therefore provide additional insight into the safety profile of a medicinal product. When a safety signal is detected, the next step is to confirm the causal association between the medicinal product and the safety concern. This is achieved by looking at the strength of the evidence, the clinical relevance, and previous awareness. Reviewing scientific literature can also help identify any similar safety concerns reported with the medicinal product in focus or with products from the same pharmacological class. In some cases, systematic literature reviews and meta-analyses can be performed to further assess a safety signal and support a more comprehensive analysis. In this scenario, the research question should be clearly formulated, and the selection of relevant publications, assessment of study quality, summary, and interpretation of findings should follow a rigorous methodology.
When searching for published papers, you need to strike a balance between casting a wide net and focusing on what is relevant to you. Make sure to include a wide range of scientific databases and journals and set your search parameters to include not only the medicinal product in question but outcome terms (e.g. headache, death), pregnancy terms (including uneventful pregnancies), and special types of reports (e.g. asymptomatic overdose, medication errors, misuse, abuse, occupational exposure). This will increase the precision of the results.
Q: How can automation help streamline the literature review process?
A: You can develop a sophisticated search strategy and end up with precise results but the amount of recalled literature can still be overwhelming, particularly for companies with hundreds of products in development and on the market.
Robust software platforms can significantly reduce effort and improve efficiency for literature surveillance activities. Standardized, automated workflows maximize the literature management process while providing a single repository for storing surveillance data. Features such as keyword highlighting, for example, streamline literature reviews and shorten the time for locating relevant information. A powerful deduplication tool will also help you by flagging duplicate results. In a pilot study, we were able to decrease the overall literature review time by up to 40% when we replaced manual processes with automated processes, using DistillerSR.
In a pilot study, we were able to decrease the overall literature review time by up to 40% when we replaced manual with automated processes once we implemented DistillerSR.
Manual Versus Automated Processes Using a Software Platform Like DistillerSR
It’s already established that the success of published literature surveillance is measured by precision and sensitivity. It is even more pertinent in a well-regulated system, such as the pharmaceutical and biotechnology industries. Performing literature surveillance under an increased level of scrutiny, as mentioned above, requires a robust literature review strategy, and relying on automated solutions. Time and quality are really of the essence while ensuring the safety of medicinal products and patients. Manual processes, using spreadsheets, are not up to the challenge of handling this volume of information and tracking it in a definitive manner
Monitoring existing and new literature for adverse events across often diverse drug portfolios can be a highly manual and time-consuming effort. A robust software platform like DistillerSR streamlines pharmacovigilance literature surveillance for transparent, audit-ready, and compliant reporting.