In the medical world, monitoring and reviewing literature at a local level has always been a challenge.
There are changing regulations, increasing sources in multiple languages, and existing workload obstacles for local affiliate offices.
This makes creating and maintaining a process for local medical literature monitoring a considerable task. Is technology the answer to expediting the medical literature review process?
Improvements from Technology Use
With the rise in AI and an increased focus on using technology to ease the burden of manual work, companies have innovated and developed technological processes to support local literature review.
Technology solutions can be used to capture data from multiple sources across digital platforms, including websites, journals, and other publications.
Print materials can also be scanned and combined with digital resources to create a full data set. This set of content can then be analyzed and searched using AI to identify articles relevant to keywords and monitoring requirements.
The relevant materials can then be securely delivered for final review and approval through a fully auditable technology. This process means that human reviewers can spend their precious time on only relevant articles and can make decisions faster and more effectively.
Here are three things to consider during this process:
Consult with Local Affiliates
For markets covered by the FDA and EMA there are guidelines set out and additional support provided. For example—see the details captured via the EMA medical literature monitoring process here.
However, it is important to understand the current process followed by each local affiliate team and what the new process should look like for them. They may have individual market-specific literature with differing access requests. There may be an additional language barrier. There could even be distinct reporting requirements depending on the country.
By mirroring their process through technology, the aim is to replicate the results while still giving them insight if they want it.
Prepare Search Strings
Getting your search string right for the products and terms you wish to monitor is key.
You may already have English strings that are working—but how often are these reviewed and updated?
When translating, have you considered that the translation of keywords should not necessarily be a one-for-one translation?
There may be additional words needed in certain languages to maximize your results.
When developing your search strategy you want to consider all the key terms you need to include, any possible variations of those terms and even common misspellings or acronyms used for those terms.
If you are searching for multiple products or areas, you may want to break terms down under these specific subject areas.
You can even delve deeper to get more accurate results by searching for words that are close together in a sentence.
Each database has its own rules for how search is conducted, so you may need to adapt your searches based on these rules, but having a subset to work from is key.
Lastly you can use Boolean logic to help refine your search—the main operators are “OR”, “AND”, and “NOT”.
OR can be used to find articles that mention any of the terms you search.
AND is used to find articles that mention all the terms you search.
NOT can be used to exclude terms from a search.
There are a lot of approaches out there so finding one that covers your search criteria will take some time, but it is worth it
One of the biggest challenges is the sheer volume of sources that require monitoring across the markets where you have distributed your product—some markets may have 10 sources, others 50.
It is important to map out your sources to identify the monitoring requirements, any paywalls that need to be accounted for, and the frequency of publications.
Once these steps have been completed, you are in a great position to look at automating the local literature monitoring process.
Tech and AI-enabled solutions for local literature monitoring will remove the burden from your local pharmacovigilance teams while providing them with greater oversight and analytics for faster decision-making.
Want to learn more about our local literature monitoring solutions? Contact us here.