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
- database studies
We can advise on all stages of study design and analysis, including
- managing studies undertaken by another provider
- writing the study protocol
- applying for ethics permission
- interacting with research networks
- writing the analysis plan
- analysing and interpreting study results
- writing the final study report
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. Therefore the importance of postmarketing pharmacovigilance cannot be overstated.
Drug Safety February 2015, Volume 38(2): 153–163
Drug Safety. 2011 December 1;34(12)
Eur Psychiatry. 2017 Jan;39:11-16.
BMJ Open. 2017 Oct 16;7(10):e016627.
Drug Saf. 2013 Apr;36(4):237-46
Drug Saf. 2013 Jul;36(7):521-31.