Clinical trial practitioners should be aware of a new European Union (EU) Clinical Trials Regulation (Regulation No 536/2014) that will require lay (plain language) summaries for every clinical trial conducted in Europe and a total of 30 countries beginning January 2022, says Kelly Vaillant, senior director for global transparency strategy and compliance at TrialAssure.
“Plain language summaries enhance trial participants’ access to information,” Vaillant says. Such summaries are important to study sites, as well as to study sponsors and vendors helping conduct trials, “to increase 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 single-entry point for sponsors, health authorities, and the public. “This centralization is a huge shift,” says Karim Ibaatene, associate director for transparency at TrialAssure. For the first time, European citizens and the rest of the world will have access to almost all study documents and data involved in EU trials, he explains.
While the regulations don’t apply to trials conducted in the U.S., Ibaatene advises “if [activity in] Europe is in your development plans, you should consider [adhering to them] from the beginning.”
Compliance with the new requirements is complicated by a number of factors, according to Ibaatene and Vaillant, including the wide scope of the changes and the fact the regulations mean many more clinical trial documents will be available to the public. “Sponsors may need a year to fully adapt to some of these changes,” Ibaatene says.
Yet while compliance sounds like it presents industry with new regulatory burdens, Ibaatene and Vaillant view it as an opportunity to raise awareness of clinical trials and instill increased trust in institutions conducting them.
“Europe has been a leader in increasing transparency in clinical research,” Vaillant notes. He also believes the initiative could ultimately spur “ancillary” projects in which information from a number of trials would be used in an aggregate manner that protects patient privacy, while alerting industry to potential and previously unconsidered uses for a prospective drug or device.
Such projects could bring added value to clinical trial research, which “today is often used for only a very narrow purpose, namely, to test a given drug or device,” Vaillant says.
Author: Michael Causey