Clinical trial practitioners should be aware of the new European Union (EU) Clinical Trials Regulation (Regulation No. 536/2014), which will require lay summaries (in plain language) for every clinical study conducted in Europe and a total of 30 countries from January 2022 . says Kelly Vaillant, Senior Director for Global Transparency Strategy and Compliance at TrialAssure.
“Summaries in simple language improve the study participants’ access to information,” says Vaillant. Such summaries are important for study centers and for study sponsors and providers who help conduct studies “to raise awareness of ongoing clinical research in the biopharmaceutical and medical device environment,” he adds.
At the center of this new regulation is the EU Clinical Trials Portal, a central point of contact for sponsors, health authorities and the public. “This centralization is a big change,” said Karim Ibaatene, associate director of transparency at TrialAssure. For the first time, European citizens and the rest of the world have access to almost all study documents and data involved in EU studies, he explains.
While the regulations don’t apply to studies conducted in the United States, Ibaatene advises “if [activity in] Europe is in your development plans, you should take that into account [adhering to them] from the beginning.”
A number of factors make compliance with the new requirements difficult, according to Ibaatene and Vaillant, including the large number of changes and the fact that the regulations will make many more clinical trial documents available to the public. “Sponsors may take a year to fully adjust to some of these changes,” says Ibaatene.
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But while compliance sounds like it is placing new regulatory burdens on the industry, Ibaatene and Vaillant see it as an opportunity to raise awareness of clinical studies and to instill more trust in the institutions that conduct them.
“Europe is leading the way in increasing transparency in clinical research,” notes Vaillant. He also believes that the initiative could ultimately stimulate “side” projects where information from a number of studies would be used in an aggregated manner to protect patient privacy while alerting the industry to potential and previously unrecognized uses for one Alert to potential drug or device.
Such projects could bring added value to clinical trial research, which “today is often only used for a very narrow purpose, namely to test a specific drug or device,” says Vaillant.
Author: Michael Causey