Dragging European Clinical Trials Rules into Operation

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Applied Clinical Trials

The entry into force of the new EU clinical trials regulation last June is really little more than a virtual event.


The entry into force of the new EU clinical trials regulation last June is really little more than a virtual event. The new rules will apply only once the EU Clinical Trials Portal and Database now under development are fully operational-and that isn't going to happen until 2016 at the earliest. In the meantime, there is a web of secondary legislation to be woven by the European Commission, which has to prepare and adopt a series of so-called delegated and implementing acts, as well as steer the process for the update of the related guidelines.

The steps needed to drag the necessary platform into place include a delegated act on Good Manufacturing Practice which will detail arrangements for inspections of investigational medicinal products, and an implementing act on detailed arrangements for Good Clinical Practice inspections, including qualifications and training requirements for inspectors. The Commission currently intends to adopt both of them by mid-2016. The necessary updated guidelines will cover GMP and voluntary sharing of raw data. And the Commission is also empowered to adopt an implementing act on cooperation among national authorities in assessing safety reporting-although it is waiting to see what comes out of discussions within the clinical trials facilitation group that national agencies operate before deciding on whether that will be needed. That group cooperates with the Commission and EMA in a specially-created clinical trials regulation coordination group that has been established to permit effective exchanges among the different bodies with responsibilities for putting the new regulation into real effect.

Over at EMA-which is responsible for creating the portal and database-work is getting underway on those tasks, and on preparing changes the agency has to introduce to the EudraVigilance clinical trial module and electronic reporting of annual safety reports. Before the portal and database can be fully activated ("no earlier than 28 May 2016," says EMA), they must be audited too. Once the EMA's management board has verified that the systems have achieved full functionality and meet their specifications, it will inform the Commission, which will in turn, after its own verification, that the required conditions are met, publish a notice in the EU's official journal-and the regulation will apply 6 months after that.


So far the agency has prepared draft functional specifications, in cooperation with experts from national authorities, and these have been endorsed by member states and signed off on by the agency's management board at its December 18 meeting.

The agency will continue progressing with the detailed design of the system and its development in 2015. Major tasks are definition of the data and document models, and agreement on appropriate labeling that will make it possible exchange them via an interface with national authorities. The work will be conducted via quarterly meetings with member state representatives, monthly meetings among experts, and teleconferences fortnightly-or more often-with subgroups formed to address specific aspects. Drug developers, patients, consumers and health care providers will be updated monthly. EMA will present timelines for the development and deployment of the system at the March 2015 meeting of its management board.

If all goes as planned, the portal, database and associated workspace should simplify and ease the approval of clinical trials in the EU. There will at last be a single entry point for submitting data and information relating to clinical trials-and the EU's hope is that the attractions of the EU as a research location will be improved by allowing easier management of multistate trials. Trial sponsors and national experts assessing trials should find life easier once the platform is in place-and the demands for greater transparency on the conduct of trials in Europe will enjoy a more comprehensive response, from the point of trial authorization to the publication of trial results.

A heady prospect indeed-particularly given the somber history of European efforts so far to regulate clinical trials. Should new year euphoria inspire a sense of keen anticipation? Or should enthusiasts hold their excitement in check until the wheels are finally attached to this elaborate wagon?