Safety profile

Often, individual studies are too small to provide a good picture of the safety profile of a drug, but by compiling evidence from all relevant studies, it may be possible to obtain a clearer picture. Systematic literature reviews offer a comprehensive overview of a health topic and are often used to make evidence-based decisions in drug safety. The DSRU has many years’ experience of conducting systematic reviews.

The Process

Studies are assessed for eligibility and quality

First the research question is formulated and eligibility criteria are specified for articles of interest. The literature is extensively searched, then the studies are assessed for eligibility and quality, the relevant data is extracted and then the results are synthesised and a meta-analysis is performed if appropriate. These systematic methods reduce the bias associated with that of general narrative reviews and therefore provide reliable results.


The DSRU uses the systematic review in a number of scenarios:

  • Risk Management: When the risk/benefit profile of a drug is uncertain, it is possible to explore the published literature and obtain further information by performing a systematic review.
  • Public Health: When an important safety issue needs further investigation, a large scale systematic review may be performed. This approach has been used within the context of the ARITMO and SAFEGUARD projects.
  • Evidence-based pharmacovigilance: to explore methodological issues in the context of drug safety.