Over 1,000 studies now recorded in EU register of post-authorisation studies

News 10/02/2017

EU PAS Register increases transparency of research in medicines after they have been authorised in the EU

The 1,000th study has been uploaded in the European Union (EU) electronic Register of Post-Authorisation Studies (EU PAS Register).

The EU PAS Register provides a wealth of information on the safety and effectiveness of authorised medicines. It is an openly accessible platform with information on post authorisation research in medicines already marketed in Europe and includes study protocols, study results, related publications and other relevant information.

The information in the EU PAS Register reduces publication bias[i] through increased transparency of medicines research, improves the quality of post-authorisation studies by facilitating peer-review of protocols and results, facilitates collaboration among stakeholders, and ensures compliance with EU pharmacovigilance legislation requirements.

The majority of studies in the EU PAS register are non-interventional, meaning the assignment of the patient to a therapeutic strategy is not decided in advance by a trial protocol but falls within current medical practice[ii], and the prescription of the medicine is clearly separated from the decision to include the patient in the study.

These studies complement the evidence generated through the clinical development programme supporting the initial marketing authorisation of a medicine. They provide valuable insight into the use of a medicine in normal clinical practice and are pivotal in fully characterising the safety and effectiveness profile once it is marketed and throughout its life span.

Regulators across the EU encourage the registration of all non-interventional post-authorisation studies, regardless of who initiates, manages or finances them. Companies must register all non-interventional post-authorisation safety studies (PASS) imposed by regulators. They are encouraged to register PASS requested to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures.

The EU PAS Register was developed through the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which is coordinated by the European Medicines Agency (EMA) to support research in pharmacoepidemiology and pharmacovigilance.

[i] A type of bias that occurs when the outcome of a study influences the decision whether to publish or otherwise distribute it.
[ii] The assignment of the patient to a particular therapeutic strategy in a clinical trial is decided in advance and does not fall within normal clinical practice.

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