Observational Post-Authorisation Studies2018-08-22T10:22:52+00:00

Observational Post-Authorisation Studies

The DSRU team is led by Professor Saad Shakir, who is probably one of the most experienced experts in Risk Management in Europe, having handled numerous drug safety risk management plans and related issues. He is supported by a team of experienced epidemiologists and statisticians. Based on their experience and familiarity with the possible options and requirements, the advice of the DSRU team is usually accepted by the EU regulatory authorities with no or minimal modifications. Over 120 drug safety studies have been completed by the DSRU, with collaborations on many more. The DSRU is an independent research organisation with charitable status and has a proven track record of conducting studies to high methodological standards.

Experienced Team

The DSRU has many years’ experience of conducting studies which are used as part of a RMP, including cohort studies conducted in primary or secondary care settings, registries, case-control studies, studies based on a number of pharmacoepidemiological databases, and systematic reviews. Our expert team comprises epidemiologists, physicians, pharmacists, biomedical scientists, statisticians, a data manager and trained coding staff.

Complete Study Package

We offer a complete study package, including the following:

  • Consultation and advice on risk management strategy
  • Design the study protocol taking account of any specific regulatory requirements
  • Write a statistical analysis plan
  • Request ethics approval and NHS R&D approval where necessary
  • Conduct the study
  • Analyse and interpret the study data
  • Write interim and final study reports
  • Publish the study in high impact peer reviewed scientific journals
  • Communicate findings at national and international conferences

Studies Utilising a Range of Data Sources

In many cases, where the DSRU team consider that the best option for a risk management study is to be conducted using other sources, such as CPRD, they provide advice and have the capabilities to advise on or conduct such studies.

Capabilities

Since the revised EU Pharmacovigilance legislation came into force in 2012, it has become a statutory requirement for pharmaceutical companies to produce risk management plans (RMPs) for a broad range of medicines. The DSRU team is heavily involved in both advising on and conducting studies which are part of RMPs. In addition, our team has experience in conducting studies to monitor the effectiveness of risk management measures.

Current Studies

Examples of studies currently underway at the DSRU:

Drug name Brand name Background Study type
Exenatide Bydureon® Bydureon is a prolonged-release suspension for injection indicated for the treatment of type II diabetes in combination with other diabetes medications in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. It was first marketed in the UK in June 2011. M-PEM
Rivaroxaban Xarelto® This study aims to monitor the short term safety and utilisation of rivaroxaban when prescribed by specialists in secondary care for the secondary prevention of atherothrombotic events in adults after acute coronary syndrome (ACS). SCEM (ROSE ACS study)
Dulaglutide Exjade® Dulaglutide is a glucagon-like peptide-1 receptor agonist indicated for the treatment of patients with type 2 diabetes mellitus. The aim of this multi-database post-authorisation safety study (PASS) programme is to assess the safety profile and utilisation of dulaglutide in the European Union. The DSRU is conducting an M-PEM study in England, and it is coordinating a multi-country collaborative research program to address common aims and objectives, using existing data from three European electronic health record databases. M-PEM and European network study
Quadrivalent Live Attenuated Influenza Vaccine Fluenz Tetra The DSRU has conducted annual Enhanced Safety Surveillance (ESS) on Fluenz Tetra, a quadrivalent influenza vaccine, every year since 2014. Vaccine Study
Biologic drugs The DSRU is conducting two similar studies, which look at the extent to which biological medicinal products (‘biologics’) are traceable within the hospital setting and how this may facilitate the reporting of an adverse drug reaction Pharmacist study x2
Impact project This project aims to measure the impact of pharmacovigilance activities by examining the evidence used to support drug withdrawals since the 2012 Pharmacovigilance Legislation and using modelling methods to measure the impact on mortality and morbidity of the withdrawals. The results of the first part of this study are available here. Methodological research under MEPS

Study Recruitment

Past Studies

FIND OUT MORE HERE

Abstracts

Publications

VIEW PUBLICATIONS HERE

To find out more about our capabilities and studies, or for an informal chat please do not hesitate to contact us

CONTACT US

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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