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The EMA and the FDA form working group on patient engagement

Tuesday, July 5, 2016

Patient engagement has been a hot topic in clinical research in recent years, and it looks like regulators may finally be catching up. Or trying to.

The EMA and the FDA have launched a new working group, also called a cluster, to focus on patient engagement. The group had its first meeting late last month. According to the EMA, the cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorization activities related to medicine. Those who focus on recruitment and engagement in the private sector are heartened by this move.

“Any time the importance of patient engagement is raised to this level of collaboration, it is extremely useful,” said Aaron Fleishman, who heads up the partner and market expansion group of BBK Worldwide, a large recruitment firm.

Pete Chan, chief innovation advocate for Tudor Reilly, a healthcare communications company in the U.K., has found that many companies are confused and lack direction to utilize patient engagement. He believes this new cluster would be a benefit for all in the industry, and clear up much of that confusion.

“At the moment, without clear and unambiguous guidance, companies have to find their own way,” Chan said. “They’re the forward-thinking and innovative companies, whereas those that are conservative and risk-averse are left waiting on the sidelines. The result is that, even though patient-centricity has become a real industry buzzword, a lot of the pharma initiatives we see are modest at best.”

Patient involvement has now become a priority for both agencies, said the EMA in a release.

“It is important to engage to be able to fully understand [patients’] needs and priorities, and make their voices heard during the course of a medicine’s lifecycle,” said Guido Rasi, EMA executive director. “Many of the challenges and benefits of working with patients are similar for both regulators.”

The increased interaction through the new cluster will allow the EMA and the FDA to share information on engaging and involving patients, while also prioritizing a scale up of future patient engagement. Areas of discussion will include the processes for selecting and preparing patients to take part in the agencies’ activities, how to ensure that patients are independent and representative and how to report on the impact of patient involvement.

Other currently existing EMA/FDA clusters are working on issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children and pharmacovigilance, among other topics.

The new cluster is expected to meet three to four times a year via teleconference and will be chaired jointly by the FDA and the EMA. The creation of this cluster is the latest step in the EMA’s and the FDA’s wider approach to expand and reinforce international collaboration.

“Patient input is growing in strategic importance because companies are realizing that clinical trials have traditionally centered on what regulators, rather than patients, consider important—with many potentially promising new drugs failing as a direct result,” Chan said.

Said Fleishman, giving patients information on the study in which they participated is an exciting area in patient engagement, and one that will surely benefit from this collaboration.

“Providing patients with post-study data is one of the newest forms of patient engagement available,” he said. “There are different regulations on how these tools can be used on a per country basis. A collaboration between both entities could lead to one set of regulations and higher adoption rates in global clinical studies.”

Will the cluster be a game changer for patient engagement? It’s hard to say. But those in the field are hopeful.

Fleishman said, “Will it change the industry’s slow adoption of newer, more patient-centric approaches? That I’m not sure about. But certainly this is a strong example of a trend that, at some point, will be the new standard—clinical research design and implementation with the patient at the epicenter.”

Success of the cluster will really depend on strong leadership within both agencies, but their decision to create this cluster gives us reason to be hopeful, said Chan.

“It’s come at just the right time for a couple of reasons,” Chan said. “First, developers of drugs recognize the need for change, and second, most patients now have ready access to health information online, meaning they’re better informed than they ever have been in the past—and as a result, increasingly qualified to have their voices heard.” 


This article was reprinted from Volume 20, Issue 26, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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