COA 2014
The Evolving Business Model of Clinical Research
Personalized medicines and targeted therapies are transforming the way cancer is treated. As these novel developments continue to evolve, so must the process of moving research findings into clinical practice, says Chris Beardmore, chief executive officer, Translational Research Management.

“What’s really exciting is that we’re going to continue to drive interest and excitement for the new therapies and novel therapeutics that are going to be coming down the pipeline,” he said. “This promotion of translational research and personalized medicine implies that research is conducted in an iterative learning system, and that process is integrated into our clinical care decision making.”

New technologies, such as cloud systems, are just one way providers of multiple disciples can share research data.

However, Mr Beardmore said that traditional studies can last 8 years, especially when factoring in the different phases and clinical trials that occur. By 2020, utilizing existing research could reduce the time it takes to complete the study process to 1.5 years.

“For example, if everybody’s out there developing a PARP inhibitor, then our confidence in the mechanism of action of PARP inhibitors will come from a lot of that existing work, and then ultimately, we will go into first-end human studies with a decent understanding of the epidemiologic data,” Mr Beardmore says. “By the time we’re done with one relatively quick clinical trial, we’ll have confidence and efficacy.”

He adds that it’s an aggressive model toward studies, but a necessary evolution. On the government side, it will require consolidating cooperative groups into a robust cancer clinical trial network. It also will require the incorporation of innovative science and incentivizing participation into clinical trials. On the industry side, Mr Beardmore specifically cites TransCelerate BioPharma Inc as group that is taking a new approach. According to the group’s mission, they “aim to simplify and accelerate the delivery of innovative medicines to patients.” Mr Beardmore added that they have integrated risk-based monitoring and implemented clinical data standards.

Mr Beardmore also said patients need to become more aware of ongoing trials. He noted that a recent annual survey found that 84% of patients are unaware of clinical trials, and only about 2% to 4% choose to participate.

“What’s frustrating to me,” he stated, “is that by and large, patients receive benefit from being in a clinical trial.”
 
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