Improving pharmacovigilance in Europe

Prescribing a drug requires understanding the balance between benefits and harms.1 Knowing these requires access to information, which can come from clinical trials or pharmacovigilance. Information about clinical trials has been much improved by trial registration in a publicly accessible database, which facilitates systematic reviews and retrieval of unpublished studies, and allows patients to volunteer for these studies.2

In the linked analysis article (doi:10.1136/bmj.c1578), Garratini and colleagues,3 like others before them,4 call for further transparency so that study results and individual patient data are made public too, with of course respect for patient confidentiality. This would allow an independent reanalysis of study results,4 and the reanalysis of combined patient safety data to ensure that the risks of drugs are not greater than their benefits and that claims of efficacy are not exaggerated.3 This would apply to studies that were submitted to obtain drug registration.

Another benefit of making individual patient data publicly available is the possibility of identifying predictors of individual patient outcomes. …