Project Description


The DSRU performs pharmacoepidemiological studies to examine the use of medications in specific populations of interest which can be designed to collect information regarding adverse drug reactions.

Be-spoke studies can be designed to:

  • Define disease burden in terms of prevalence, incidence, cost, disability and potential complications
  • Examine patient demographics, characteristics and risk factors
  • Perform drug utilisation studies
  • Identify and examine patient outcomes including adverse drug reactions, clinical events, laboratory test results and general health parameters

Analytical methods

We are experienced in the application of a wide range of pharmacoepidemiological analytical methods and can advise on all aspects of study design, methods and analysis including:

  • Non-interventional observational cohort studies
  • Self-controlled study designs
  • Descriptive statistics
  • Regression modelling
  • Survival analysis techniques
  • Multi-level modelling
  • Time-series methods

Data sources

The DSRU uses a broad range of data sources and research networks and can provide expert advice regarding the best data source to use based on study aims, regulatory requirements and statistical criteria. Data sources include:

  • Internal DSRU sources utilising the Modified-Prescription Event Monitoring (M-PEM) or Specialist Cohort Event Monitoring (SCEM) methods. These are non-interventional methods in which patients are identified from dispensed prescriptions and information is collected from prescribers
  • Electronic health record databases (e.g. Clinical Practice Research Datalink)
  • In-house disease registries as well as disease registries in the UK and across Europe

Study objectives

In the post-marketing phase, observational studies in pharmacoepidemiology can be employed to:

  • Examine drug utilisation in real life settings in general or special populations, including off-label use, misuse and medication errors
  • Examine potential risks, identified risks and missing information as outlined in a products Risk Management plan
  • Study the overall safety profile of a medicinal product
  • Examine safety signals identified from spontaneous reporting or other sources

Our multidisciplinary team of pharmacoepidemiologists, clinicians, research scientists and regulatory experts can design studies to fulfill regulatory requirements, ensuring they meet our quality scientific standards.

Please contact us for an informal discussion

T: +44 (0) 23 8040 8600

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Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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