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Drug Safety Research Trust

Southampton, GB

The Drug Safety Research Unit (DSRU) is an independent academic unit internationally respected for its work in Pharmacovigilance, Pharmacoepidemiology, Risk Management and Training Services for over 30 years.

In partnership with doctors in England, the DSRU, led by Director Professor Saad Shakir, aims to protect patients in primary and specialist care from unwanted adverse effects of newly marketed medicines using our unique methods of monitoring patients during the lifecycle of medicines.

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Pharmacovigilance and Post-Authorization Safety Studies
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The DSRU has many years’ experience of providing advice on and conducting studies for Drug Risk Management Plans (RMPs). We have expertise in designing protocols that are scientifically robust according to good pharmacoepidemiological practices, as well as meeting the methodological standards required by regulators. The DSRU can... Show more »

The DSRU has many years’ experience of providing advice on and conducting studies for Drug Risk Management Plans (RMPs). We have expertise in designing protocols that are scientifically robust according to good pharmacoepidemiological practices, as well as meeting the methodological standards required by regulators. The DSRU can also provide advice on constructing a study protocol or the practicalities of undertaking a study.

Since the early 1980s, the DSRU has undertaken and advised on pharmacovigilance studies both in the UK and Europe. We have extensive experience of conducting a range of pharmacovigilance studies in both primary and secondary care involving General Practitioners (GPs) and specialists, including case- control studies, cohort studies, registries and database studies. We can advise on all stages of study design and analysis, including writing the study protocol, applying for ethics permission, interacting with research networks and more.

Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” (WHO). Randomised controlled clinical trials (RCTs) provide a lot of information on safety in selected treated populations under conditions governed by study protocols. However, this information is limited. Further data from post-marketing studies are needed to inform on safety in populations intended to be treated under real-life conditions. RCTs are often of insufficient size or duration to inform on rare adverse events, particularly in special populations. They also often have exclusion criteria making the study population unrepresentative of those likely to be treated in the general population, and thus subsequently results may not be generalisable. Therefore the importance of postmarketing pharmacovigilance cannot be overstated.

In pharmacovigilance, a Risk Management System is “A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions” (Good Pharmacovigilance Practice (GVP) Module V).

All drugs have risks associated with their use, including adverse reactions, interactions between drugs and with environmental factors, as well as the risk that the product may not work as effectively as expected. The key point is the balance between benefits and risks. To optimise this balance the aim must always be to maximise benefit and minimise risk. Regulators, health professionals, manufacturers and patients all are required to perform risk management activities.

The importance of risk management has increased dramatically since July 2012 when the revised EU Pharmacovigilance Legislation came into force, requiring that every new medicinal product has an RMP. There are many other instances when submission of a RMP may be required during the lifetime of a medicine, as listed in Good Pharmacovigilance Practice (GVP) Module V. Thus having a RMP in place allows for a proactive approach to better understand risks already identified but not fully understood, as well as potential risks where there are suggestions that they may occur and information missing from premarketing development programs. Also where necessary, the RMP includes actions to prevent, mitigate or manage specific risks post-authorisation. The DSRU has conducted studies to monitor and assess the effects of risk minimisation measures.

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Epidemiological Study Design
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Pharmacoepidemiology

Pharmacoepidemiological studies examine the use of medications in populations of interest (including any effects from their use such as adverse drug reactions). Such studies can be used to:

  • define disease burden in terms of prevalence, incidence, cost, disability and potential complications
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Pharmacoepidemiology

Pharmacoepidemiological studies examine the use of medications in populations of interest (including any effects from their use such as adverse drug reactions). Such studies can be used to:

  • define disease burden in terms of prevalence, incidence, cost, disability and potential complications
  • examine patient characteristics and drug utilisation
  • examine outcomes including the safety of medicines

In post-marketing, pharmacoepidemiological studies can be used to:

  • examine drug utilisation in real life settings in special populations, including off-label use, misuse and medication errors
  • examine potential risks, identified risks and missing information as outlined in a product’s 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 epidemiologists, statisticians, clinicians and research scientists can design studies to fit regulatory requirements, ensuring that they meet our high standards. We are experienced with the application of a wide range of pharmacoepidemiological methods and can advise on all aspects of study design and analysis including survival techniques and self-controlled designs using a broad range of data sources (internal DSRU sources as well as other sources across Europe).

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Clinical Research
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Epidemiology, HEOR, and Post-Authorization Studies
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