Entire clinical research model at risk: ‘Call to action has to be now,’ says PRA

“The real world is quite quickly going to surpass drug development and put the entire model that we have at risk,”​ said Kent Thoelke, executive vice president, scientific, medical affairs and safety, commercialization services, PRA Health Sciences, at the inaugural Bridging Clinical Research and Clinical Health Care collaborative earlier this month.

Many oncology trials are recruiting at a number of half a patient per site per month and cost $2 to $3bn to get to market, said Thoelke, adding that the model “isn’t going to get better.”​

Compounding recruitment challenges, 30% of the millennial generation doesn’t have a primary care physician – and they are expected to overtake Baby Boomers as America’s largest generation by 2019​.

Instead, the digitally-driven generation receives health care through ambulatory clinicians or telehealth. As such, these patients are “lost to participate in clinical trials”​ because “they don’t fit​” into the industry’s current “brick and mortar system,”​ said Thoelke.

“These timelines aren’t going to get better and the financial models will not sustain trials that take five or six years to recruit patients,”​ he added.

Thoelke said the industry needs to shift its mindset that the patient is different: “Patients are consumers. They are the same people outside of the trial who get up every morning and use their smartphone … they live in a world that is fully mobile.”​

However, when a patient participates in a clinical trial, they must “step out”​ of this world and into a “highly paper-driven model.”​ Yet the industry today has the ability to use mobile health technology to lower the barriers to entry and increase access to clinical trials, Thoelke said.

“Patients die every day because of the process we’ve created, because it takes too long,”​ he added. “The call to action has to be now.”​