This blog features:
- What is Literature screening?
- Characteristics of Literature screening
- Key takeaways
Table of Contents
Introduction
In pharmacovigilance, several activities are performed to monitor the safety of medicinal products throughout their lifecycle. One of the important sources of safety information is the scientific and medical literature.
Previously, the literature process was discussed in very few areas in the context of ICSR (Individual Case Safety Report) case processing. However, literature management in pharmacovigilance involves several stages before reaching the case processing phase. One of the critical early stages is literature screening.
So this section provides an overview of literature screening, its purpose, characteristics, and the criteria commonly used to identify relevant articles in pharmacovigilance activities.
Literature screening: An overview
Literature screening is the systematic process of reviewing and evaluating the publications retrieved from a literature search in order to determine their relevance to a predefined research question, safety concern, or pharmacovigilance objective.
The screening process helps identify publications that may contain important information such as adverse drug reactions, safety signals, drug–drug interactions, or other clinically significant observations related to medicinal products.
“Literature screening is not just filtering articles; it is the disciplined process of identifying the evidence that truly matters.”
Typically, literature screening is performed in two stages:
- Title and Abstract Screening – A preliminary review where the title and abstract of each retrieved article are evaluated to determine potential relevance.
- Full-Text Screening – A more detailed assessment of the complete article to confirm whether it meets the predefined criteria.
Characteristics of Literature Screening
The literature screening process has several important characteristics that ensure the selection of relevant and high-quality evidence.
- Conducted after literature search
Literature screening takes place after retrieving search results from scientific databases. The screening stage begins once the initial search results are collected. - Initial evaluation of title and abstract
In the first step of screening, reviewers examine the titles and abstracts of retrieved publications to quickly determine whether the article may be relevant to the research objective. - Sequential review of publications
Articles are reviewed individually, either manually by reviewers or using automated tools that assist with prioritization and filtering. - Assessment of relevance
Each publication is assessed to determine whether it aligns with the objective of the literature search, such as identifying safety information related to a specific drug or adverse event. - Segregation of relevant articles
Publications that meet the predefined criteria are separated from those that are not relevant to the research question or safety objective. - Prioritization for further evaluation
Relevant articles are prioritized for the next stage of evaluation, such as full-text review, safety assessment, or case extraction. - Removal of irrelevant publications
Articles that do not meet the inclusion criteria are excluded during the screening process to reduce unnecessary workload during later stages. - Involvement of multiple reviewers
In many systematic review processes, more than one reviewer participates in the screening process to ensure accuracy, reduce bias, and improve reliability. - Use of predefined screening criteria
Every literature screening process is guided by specific criteria that define which studies should be included or excluded.
Examples of Screening Criteria:
Screening criteria are defined before starting the literature screening process. These criteria help ensure consistency and transparency in selecting relevant studies. Every literature screening does involves exclusion and inclusion criteria as pre-defined based on your intent. The few examples down below:
- Studies conducted in human subjects
- Paracetamol as drug name
- Studies published after a specific year
- Studies related to a specific disease or therapeutic area
- Publications reporting adverse drug reactions
If the above-mentioned points represent the inclusion criteria, the exclusion criteria may include the following:
- Animal studies
- Studies without any medicinal products involved
- Publications outside the defined time period
- Studies that do not report any diseases, adverse events, or safety-related outcomes** relevant to the objective of the search.
- Publications written in languages that are not included in the criteria
Key takeaways
Literature screening is a critical step following literature search.
The screening process typically begins with title and abstract review, followed by full-text assessment to confirm whether the publication meets predefined inclusion criteria.
Inclusion and exclusion criteria guide the screening process, helping reviewers systematically identify relevant studies.
Literature screening helps reduce large volumes of search results, allowing researchers to focus only on outcomes.
The process often involves multiple reviewers and structured evaluation methods
Struggling to screen the articles?
Thousands of articles are published every day, but only a few contain information that truly matters for drug safety.
Improve your screening strategy and streamline your pharmacovigilance literature review process with Drugvigil
Conclusion
Literature screening is an essential step in pharmacovigilance literature management. It enables researchers and safety professionals to efficiently filter large volumes of search results and identify relevant publications that may contribute to safety evaluation and evidence generation.
By applying this knowledge you can understand what is structured criteria and systematic evaluation methods, literature screening ensures that the most relevant and reliable information is selected for further analysis.
Leave a Reply