Many post-authorization studies registered with the European Medicines Agency (EMA) fail to comply with legal requirements and recommendations to make their findings public, finds a study published by The BMJ. Post-authorization studies (PAS) are carried out after a medicine is approved to collect further “real-world” data about its safety and effectiveness. The results show that only six of every 10 finalized and ongoing post-authorization studies had uploaded a protocol and less than seven of every 10 finalized post-authorization studies had uploaded results to the EMA’s database.
This article was originally published on MedicalXpress.com
