Clinical Research Challenges: Current model is too slow, too costly


An industry expert says the current model for conducting clinical research is “failing patients who live in a mobile world and will not sustain itself if clinical trials take years to recruit,” writes Melissa Fassbender in

This scenario puts the entire clinical research model at risk, according to Kent Thoelke, executive vice president of scientific, medical affairs and safety, commercialization services, at PRA Health Sciences.  Thoelke, who spoke at the first Bridging Clinical Research & Clinical Health Care Collaborative April 4 to 5, in ational Harbor, Maryland, said, “The real world is quite quickly going to surpass drug development and put the entire model that we have at risk, and it isn’t going to get better.” He added that numerous oncology trials are recruiting at a rate of half a patient per site per month with drugs costing $2 to $3 billion to get to market.

In addition to the current recruiting challenges, the fact that 30 percent of millennials have no primary physician compounds the problem, as millennials will overtake baby Boomers as the country’s largest generation by 2019. Because millennials get health care by means of ambulatory clinics or online, their profiles are not in the industry’s system of potential clinical trial participants. If clinical trials allowed for participation via smart phone, they could cut down on recruiting time and enable broader participation, thus reducing costs and bringing products to market faster.

The Bridging Clinical Research & Clinical Health Care Collaborative brings together representatives from industry, clinical research, health care, patient advocacy groups, regulatory agencies and academia to seek a true collaborative solution to build a bridge between clinical research and health care, according to its website. Its mission is “to bring together clinical research and health care professionals to increase patient and physician participation in clinical trials.” The group believes that increasing participation by just 3 percent would be an enormous step toward improving the sustainability of clinical trials. As the group explains, “We all want to get new medicines and new treatments to the market faster. But clinical researchers can’t accelerate trials when patients and health care providers — who have vital roles — either aren’t aware or aren’t interested in clinical trials.”

Thoelke wants to see the life sciences industry changing its mindset that patients who get health care in a different format than those of previous generations are different. He wants health care providers and researchers to view all patients as consumers and understand that some of them view health care through a different lens. If clinical trials could utilize existing technology that is favored by younger consumers, both recruitment and compliance would be simpler and more efficient. It would “lower the barriers” to participation by a broad spectrum of people.

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


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