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, registries and database studies. We can advise on all stages of study design and analysis, including writing the study protocol, applying for ethics permission, interacting with research networks and more.
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. RCTs are often of insufficient size or duration to inform on rare adverse events, particularly in special populations. They also often have exclusion criteria making the study population unrepresentative of those likely to be treated in the general population, and thus subsequently results may not be generalisable. Therefore the importance of postmarketing pharmacovigilance cannot be overstated.