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Pharmacovigilance at PRIMENT

NathanDavies6 May 2016

What is pharmacovigilance and why is it important?Charlene Green

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problems. It’s an important discipline because it allows us to find out what safety issues relate to a drug with the aim of improving patient care and safety. Without pharmacovigilance we would be giving potentially harmful drugs to patients without monitoring their effects! There is also a specific legal requirement to monitor the safety of drugs in clinical trials.

So what are we doing here at Priment?

Historically, Priment has typically been involved with non-drug clinical trials (psychological interventions, qualitative research etc.) but there has been a desire over the past year or so to expand the research portfolio to include clinical trials of investigational medicinal products (CTIMPs) i.e. drug trials. To be able to achieve this Priment has excitingly developed a PV system and we can now support researchers at all stages throughout a trial with their PV needs. It’s an exciting time for the unit as we are taking on PV responsibilities for two really interesting trials, KIWE and PANDA.

KIWE is a trial that is investigating the use of the ketogenic diet in infants that have epilepsy. They would otherwise have to rely on years of anti-epileptic drug treatment so the findings will be really important for these children and their families. The trial team are based at the Institute of Child Health.

The PANDA trial is comparing the use of an anti-depressant drug (sertraline) with placebo in patients that have depression to find out who might fully benefit from anti-depressants. The team are based at the Institute of Psychiatry and we are also working with them on another trial that will join the Priment portfolio in a few months.

Why?

PV in clinical trials is new to many of the researchers working at/with Priment so we wanted to be able to ensure a consistent approach to this aspect of our work and to be sure that we are working in line with the regulations. By centralising PV we are taking away a barrier to starting work on CTIMP trials and hopefully giving researchers an added benefit of working with Priment as we expand our portfolio.

How Priment supports CTIMPs

We are involved from the protocol development stage right through to trial closure and provide support on protocol development, adverse event management, training, periodic safety reporting and the management of reference safety information (to name a few things!). We are here to support trial teams throughout the clinical trial lifecycle and will endeavour to do our best to provide answers to queries and problem-solve whenever necessary.

What does this mean for Priment?

Priment ‘sits’ within 2 of UCL’s Institutes – the Institute of Epidemiology and Health Care  (IEHC) and the recently formed Institute of Clinical Trials and Methodology (ICTM).  The inclusion of clinical trials into Priment’s work allows us to contribute to the achievement of the aims of both, notably ‘Evaluating strategies for the prevention & treatment of physical ill health’ (IEHC) and ‘To improve local, national and global health by conducting clinical trials and other well-designed studies’ (ICTM).

What next?

The Priment portfolio of CTIMPs is expanding and we are working on 2 more trials which we hope will be open by late 2016/early 2017. They are RADAR and ANTLER:

The RADAR trial is comparing the use of an anti-psychotic drug reduction programme with maintenance treatment in patients that have schizophrenia and psychosis. By slowly tapering patients off their treatment it is hoped that the unpleasant side-effects of the drugs may be avoided while hopefully keeping patients well.

The ANTLER trial is also investigating a drug reduction programme but this is for patients with depression. An anti-depressant drug reduction programme is being compared to maintenance treatment to find out which types of patients can benefit from reduced drug treatment.

For more information about PV at Priment, or to find out how we may assist you with your trial please contact Charlene Green (PV Coordinator).

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