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.
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 its unique methods of monitoring patients during the lifecycle of medicines. The Unit works directly with prescribers in both primary and secondary care in order to gather data for its observational studies.
The DSRU has many years’ experience of providing advice on and conducting Post-Authorisation Safety Studies (PASS). 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.
DSRU Consultancy provides advice on strategies, study designs and options for post-marketing Pharmacovigilance, Pharmacoepidemiology and Risk Management Planning in the EU. The DSRU has experience in handling a very broad range of products, from those that are widely used to small niche highly specialised medicines.
Our expert team of epidemiologists, medics and pharmacists offers a full study design package, based on many years’ experience of writing protocols and conducting studies. We have a good understanding of regulators’ expectations and have never had a study proposal rejected by a medicines regulator.
• Impeccable track record of providing impartial advice
• Good understanding of regulators’ expectations
• Flexible service:
o Advice only OR ongoing consultancy for particular pharmacovigilance issue OR full study package
o Use of DSRU’s own data sources or other databases
o Big or small pharma or other organisations
o Observational studies in UK or network of European centres
DSRU Consultancy is proud to offer world-class science at a not-for-profit price.
The DSRU has more than three decades’ experience of epidemiology and post-authorisation studies (PAS). Our team of postgraduate epidemiologists is supported by the DSRU’s research team comprising medics, pharmacists and biomedical scientists. We have wide experience of designing and undertaking PAS in primary and secondary care in the UK. Our unique SCEM methodology (Specialist Cohort Event Monitoring) involves working directly with prescribers of a given drug in hospitals or specialist units.
We also conduct European network studies, heading a network of partner organisations in order to design and undertake PAS studies in several European countries.
We have access to the Clinical Practice Research Datalink (CPRD) and have experience of conducting studies on this data.
The DSRU has gathered real world data since the 1980s, in the form of event data from medical records provided by prescribers in primary or secondary care. This direct access to prescribers is a great advantage in the field of pharmacoepidemiology as it allows us to gather the bespoke data set required for a post-authorisation study, without relying on existing databases. These are the data sets used for our Modified Prescription Event Monitoring (MPEM) methodology in primary care and our Specialist Cohort Event Monitoring (SCEM) methodology in secondary care.
We also have experience of conducting patient surveys, mostly in the form of Enhanced Safety Surveillance on flu vaccines.
We can collect data from patients or health care professionals either on paper or online using our in-house bespoke online data capture system.
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).
The DSRU has been conducting observational/ non-interventional studies since the 1980s. Get in touch to find out more about our experience of conducting studies in both primary and secondary care in the UK or as a network of European countries. Our capabilities include post-authorisation safety studies (PASS), risk minimisation studies, measuring the effectiveness of risk minimisation measures, registries, drug utilisation studies and much more.
DSRU Education & Research Ltd has been providing training in drug safety since 2000. We now have a portfolio of 15-20 short courses on a variety of topics related to pharmacovigilance, pharmacoepidemiology and risk management. We also offer one or two conferences each year, including our biennial Signal Detection conference, the European Conference on Risk Minimisation, and Big Data for Pharmacovigilance.
Since 2010 we have offered a postgraduate programme, leading to MSc in Pharmacovigilance, in association with the University of Portsmouth. This flexible course is based on attendance at our short courses plus completion of coursework, and is designed with the full-time pharma employee in mind.
The DSRU is also the Faculty of Pharmaceutical Medicine’s recognised provider of the Drug Safety Surveillance (DSS) module of Pharmaceutical Medicine Speciality Training (PMST) for pharmaceutical physicians.
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