EMA Delivers Disappointing Clinical Trials News

Dec 30, 2015

The December meeting of the European Medicines Agency's management board offered tidings of less than total comfort and joy to the clinical trials community. The agency's holiday message was a disappointment to those hoping for rapid progress on bringing Europe's new clinical trials rules into effect. The legislation, finalized in May last year—that is, 2014—said the new regulation would not be in force before May next year—that is, 2016. But the EMA board, which had already admitted that 2017 was a more likely date, disrupted the festive season with the news that the horizon for the clinical trial rules had shifted still further away, and is now October 2018. 

The announcement has provoked some sharp reactions among those battling with the incoherencies of the EU's current rules on clinical trials—which the new regulation was designed to remedy. The agency's protestations of the need for a meticulous approach have not assuaged the impatience of development staff still laboring through the complexities of the much-criticized 2001 directive.

"The clinical trials regulation involves a very significant overhaul of the processes for authorization and oversight of clinical trials," said the agency in defense of the new delay in implementation. It is an "ambitious project" and "it is of critical importance that the EU system provides the required functionalities to all stakeholders in the most efficient and stable way from the start of its operations." It is hard to resist the thought that even that phrase seems to take an undue time to deliver its meaning!

The new rules, adopted by European politicians in the European Parliament and the Council of Ministers, gave the agency a key role in setting up the mechanics for the new system: a clinical trial portal and a database. The portal will provide a one-stop shop for submitting and maintaining clinical trial applications and authorizations, and for supporting a coordinated approach to assessment and supervision. The database will provide public information on the lifecycle of all clinical trials conducted in the EU, from their initial review up to publication of their results.

The timeframe endorsed by the agency's board will, it says, enable "the robust development and testing of the system and allow resolving unforeseen difficulties and potential issues." The aim is to have the database and portal ready for independent audit by August 2017. And "if the system gets a green light from the audit, the EU Clinical Trial Regulation will come into effect by October 2018 at the latest."

That shaky, conditional, reassurance rings a little hollow. It took years to put the 2001 directive on the statute book, and almost as soon as the ink was dry on it the EU admitted that the many criticisms of it were justified, and that it wasn't fit for purpose. Almost immediately, work started on the new regulation. But after so many delays and disappointments, confidence in the reform process is leaking away. Not much credence is being given to the board's attempt to shore up belief with its emphasis—at the end of its December announcement of the new date—that "this is a maximum timeframe and that all possible efforts must be made to shorten it and bring the regulation into operation as soon as possible."  It is, for many in the clinical trials world, just too slow—and condemns everyone to carry on working with a defective set of rules right up to the end of 2018—and possibly longer.

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