Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

EMA Clinical Data Transparency: A Critical Synopsis ***

Manuel Bilke (Abschlußjahr: 2016)

Summary
Language: English
This thesis aims to answer the question what the current status on EMA clinical data transparency is.
A systematic evaluation of applicable European legislation serves a basis for this synopsis where Directive (EC) 2001/20, Regulation (EC) 1049/2001, Regulation (EC) 536/2014, and Policy 0070 are to be mentioned as the most important. A particular focus is layed on the European databases EudraCT, the EU Clinical Trials Register and the EU Portal.
This comparison eventually results in a comprehensive table that informs about who has to publish clinical data, what is the extent and scope of clinical trial data to be published, when they are to be published and where.
The Clinical Trials Regulation that is planned to come into force in October 2018 introduces clinical data transparency targeted at the lay audience. According to the regulation, a lay summary of study results is to be submitted to the EU Portal. Dependant on how easily accessible this EU Portal will be to the public and to search engines this lay summary will be one influencer of the lay person’s shaping of opinion on a drug’s properties.
EMA has undergone a fundamental paradigm shift in regards to clinical trial transparency:

• Change from reactive to active clinical data transparency 

• Publishing of results regardless of the outcome 

• Phase 1 to Phase 4 

• Two dominating restricting principles: Protection of personal data and protection of commercially confidential information.

It becomes obvious that there exist clinical data publishing obligations deriving from a multitude of different legislations that coexist in parallel and independently. This greatly impacts the daily work of the Regulatory Affairs Manager and compliance with all publishing legislations adds another layer of responsibility to his or her expertise.
Pages: 33
Annexes: Pages 2