The DSRU Centre for Pharmacovigilance Methodology
The Centre for Pharmacovigilance Methodology builds on the DSRU’s widely-quoted methodological research in pharmacovigilance and pharmacoepidemiology. The launch of the Centre marked a major expansion in the DSRU’s methodological research, both to improve existing methods and propose new ones, both in-house and through some exciting new collaborations.
The Centre is staffed by a small team of DSRU physicians, epidemiologists and biomedical scientists dedicated to methodological research in the field of drug safety.
Current activities of the Centre for Pharmacovigilance Methodology :
- International Working Group (IWG) on Signal Detection and Management in Pharmacovigilance – see the IWG page for further details.
- Investigating the impact of product withdrawals, revocations, and suspensions on public health burden within the EU
- Assessing safety evidence available at the time of significant “drug scares” within Europe
The team at the Centre for Pharmacovigilance Methodology has expertise in the concept, design, implementation and completion of these methodological studies, as well as a broad range of experience in pharmacovigilance and pharmacoepidemiology.
The DSRU hopes to extend the theory of Evidence-Based Medicine (EBM) methodology, which promotes the use of the best available evidence in clinical and regulatory decision making, for use within pharmacovigilance. There is a clear need to integrate the concepts of EBM into pharmacovigilance as these studies can aid in the understanding of drug safety issues as well as identifying areas of additional research. It is important to recognise that the evidence for a drug safety issue may come from a number of study types and resources; appropriate methods are therefore required to search relevant resources and identify suitable evidence for use during pharmacovigilance activities.
The DSRU has previously conducted a number of methodological studies using systematic searches of the medical literature and other pharmacovigilance resources such as regulatory websites, to evaluate different issues relevant to the safety of medicines.
Completed methodological studies include:
- Investigations into the evidence used to support regulatory actions, such as withdrawal of products from market, in Europe and the United States
- An assessment of the quality and conduct of systematic reviews of adverse effects of drug interventions
- An investigation into the application of exclusion criteria in pharmacoepidemiological studies
- An assessment of the use of the Bradford Hill criteria for the causal assessment of cisapride-induced arrhythmia
For further details please see the Related Publications below.
BMJ Open 2018;8:e019759. doi: 10.1136/bmjopen-2017-019759
BMJ Open. 2014 Jan 15;4(1)
Drug Saf. 2006;29(2):175-81.
Drug Saf. 2007;30(4):333-46.
Pharmacoepidemiol Drug Saf. 2009 Dec;18(12)
Pharmacoepidemiol Drug Saf. 2007 Mar;16(3)