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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.
22nd October 2015
Additional risk minimisation measures and monitoring their effectiveness are the new kids on the block. Regulatory authorities understandably require studies to demonstrate that additional risk minimisation measures actually work when applied for a particular product. Module XVI of GVP is about additional risk minimisation and studying its effectiveness.
People look at studying effectiveness of risk minimisation with some trepidation, probably because of its novelty and their uncertainty about what is required and how it can be done. We have learnt from our first Risk Minimisation conference in November 2014, that everyone (regulators, research providers, industry) is at the steep phase of the learning curve. We also realised that the "last words" on the matter have not been said.
Notwithstanding the understandable uncertainties, the basic principles are clear. Key to successful monitoring is a clear understanding of the objective(s) of the additional risk minimisation. For example, is it adherence to prescribing information, does it require predetermined conditions (e.g. a normal laboratory test) prior to use of a drug or does it aim to change the behaviour of prescribers, (e.g. rigorous selection criteria for patients prescribed a particular drug). Once these are defined and technical matters such the study setting and sample size are decided, then it remains to apply general research and epidemiological principles to achieve the aims of the study.
Nothing in science or pharmacoepidemiology is easy nor should be taken for granted, but it is also true that given relevant experience, proper understanding of the objectives of the additional risk minimisation will facilitate conducting studies that answer the questions effectively and meet regulatory requirements.
Risk minimisation is a journey: we hope that the Second European Conference on Monitoring the Effectiveness of Risk Minimisation will extend the sharing of knowledge and experience which will move our understanding another step forward.
The 2nd European Conference on Monitoring the Effectiveness of Risk Minimisation takes place on 11th -12th November 2015, with a pre-conference tutorial day on 10th November. For conference information and registration click here.View our latest news