Members of the largest demographic group in American history have been online since early childhood, probably don’t have a primary care physician, and pretty much expect their healthcare to be delivered how and when they want.
Whether it’s via telehealth, using mobile apps, or other technologies, today’s so-called Millennials or Generation Y children—born roughly between 1981 and 1996—are about to turn the world of clinical trial patient recruitment on its head, leading experts said at the 9th Annual DPharm: Disruptive Innovations conference in Boston yesterday (September 17).
“Patient recruitment has always been an Achilles heel in this industry,” said Joseph Kim, MBA, senior advisor for clinical operations and digital registry at Eli Lilly & Co.
Virtual, mobile-infused trials are “the future, and there’s a huge interest from the Food and Drug Administration” (FDA) to promote them, said John Whang, MD, IET head for cardiovascular and metabolism at Johnson & Johnson. “Don’t let the FDA scare you, I think they’re on our side.”
Whang is a big proponent of so-called siteless trials. He’s currently engaged with Kent Thoelke, executive vice president and chief scientific officer at PRA Health Sciences, on a trial designed to recruit 5,000 patients without use of a single physical site. “We’ll report back next year,” Thoelke said, though early indications are the project is off to a good start.
Acknowledging siteless trials don’t work in all situations, and that hybrid trials will be more the norm over the next several years, Thoelke nevertheless said the current site-based model “will be extinct in five years if we don’t make some disruptive changes” to appeal to the Millennial population.
The current clinical trial model is “broken,” Whang said. Too slow and expensive, by his reckoning, he says one key to success for clinical trial practitioners moving forward is to have “the right kind of mindset” open to change.
“Where are we going to get patients for our trials” if we begin to lose Millennials, Thoelke said. “If we believe we can force Millennials into our current paradigm, we’re sadly mistaken.”
With many studies showing it is in fact primary care physicians who most often steer patients toward participating in a clinical trial, industry would be wise to fire up those patients who have already participated in the hopes they’ll return and/or recommend the process to a family member or friend.
Unfortunately, many trial participants feel somewhat discarded and “unimportant” after their trial, or their role in it, is over, said Ken Getz, director of sponsored research at the Tufts Center for the Study of Drug Development and founder of the Center for Information and Study on Clinical Research Participation. More than 90% want some kind of plain-language summary of the trial results, and industry too often fails to provide it. “We should be embarrassed,” Getz said at DPharm.
The summaries are inexpensive and the “impact on patient satisfaction is huge,” Getz said.
Other considerations aside, there’s a compelling reason to share more information with the very people making the effort to participate in clinical trials. “It’s the right thing to do,” said Paulo Moreira, global head of clinical operations at Agenus.
Author: Michael Causey