The European Medicines Agency met in December to discuss clinical trials, but the results were not favorable. They delivered a message that no one in the trials community wanted to hear: they are pushing back legislation on clinical medicine trials. Many hoped to see progress with new trial rules for Europe, but earlier confirmations showed […]
The European Medicines Agency met in December to discuss clinical trials, but the results were not favorable. They delivered a message that no one in the trials community wanted to hear: they are pushing back legislation on clinical medicine trials.
Many hoped to see progress with new trial rules for Europe, but earlier confirmations showed that the regulations — which were finalized in May 2014 and said to begin in May 2016 — would be pushed back to 2017 at least. This latest announcement pushes them back even further, to a likely date of October 2018.
Thousands of drugs are synthesized during the research and development stage, but just one in 5,000 will actually make it through clinical trials and the approval of the U.S. Food and Drug Administration or other governing body. So what are people saying to this consistent push for new rules?
To put it simply, there have been strong reactions. Many say that the current rules are incoherent and that the new rules are needed sooner in order to clarify any issues. However, the agency says they are taking their time with the regulations to ensure they make it through the most complex parts of these rules, which were introduced in a 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!
These rules will be playing a large role in setting up a new system, as soon as they are finalized by the agency and approved by the European Parliament and the Council of Ministers. The system will streamline applications for trials, as well as authorizations. In addition, it will provide a database for all trials to the public.
The timeline supported by the agency’s board will 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,” the agency said.
It’s not the only set of regulations currently under fire, either. Research shows that nearly 20% of publicly funded studies on cancer cures fail to produce the amount of patients for accurate outcomes. This is likely due to a stalemate in progress for cancer drugs. In fact, one study from Fred Hutchinson Cancer Research Center and the University of Washington called these studies, “a waste of scarce human and economic resources.”
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