IMI project recommends caution when assessing medicine impact studies from different databases

PROTECT suggests analysing databases in parallel and exploring reasons for potentially different drug monitoring results through 'extensive sensitivity analyses'

An Innovative Medicines Initiative (IMI) project coordinated by GlaxoSmithKline and the European Medicines Agency (EMA) has generated careful advice about accurately assessing pharmacovigilance information from different datasets.

The 2009–2015 PROTECT project aimed to produce guidance on tapping different sources of information about the impact of authorised medicines. Its conclusions have now been released and its key message is caution.

'Conducting multi-centre database studies requires very detailed common protocols and data specifications that reduce variability in interpretations by researchers,' said guidance released by the European Medicines Agency (EMA).

EMA said PROTECT researchers had found that ‘a priori’ pooling of data from several databases 'may disguise heterogeneity that may provide useful information on the safety issue under investigation'. PROTECT prefers analysing databases in parallel and exploring reasons for potentially different drug monitoring results 'through extensive sensitivity analyses'.

Such an approach, said the guidance, 'will eventually increase consistency in findings from observational drug effect studies, or reveal causes of differential drug effects'.

Peter Arlett, Head of EMA’s pharmacovigilance department, commented: 'Results are being implemented into routine pharmacovigilance and regulatory practice. They have already started to improve day-to-day medicines monitoring operations of regulators and pharmaceutical companies, for better safety of European patients.'

Other PROTECT conclusions have highlighted the need for access to drug utilisation data and national drug consumption databases, as well as registering protocols of drug-adverse event studies in an electronic public register.

Details of the PROTECT research have been published in a special issue of the journal Pharmacoepidemiology and Drug Safety.