Clinical trials should be happening in the community, said Timothy Yeatman, MD, surgical oncologist and President and Chief Scientific Officer, Guardian Research Network, and President, Gibbs Cancer Center, Spartanburg, SC, at the 2016 Association of Community Cancer Centers (ACCC) National Oncology Conference.
Dr Yeatman founded the Guardian Research Network, a nationwide network of largely oncology community centers and hospitals, to support and enable community centers to participate in clinical trials, democratize access to clinical trials, with the goal of revolutionizing drug development.
According to the National Cancer Institute, 85% of patients with cancer receive treatment at community centers or hospitals in or near the communities in which they live, but less than 3% of patients ever get access to clinical trials (1.5% for minorities). Overall, 60% of sites fail to enroll a single patient, costing drug developers up to $170,000 per trial site, and leading to reduced resources.
“We are facing a huge problem: 800 to 1000 drugs need to be tested, but the great irony is that patients don’t have access to them,” Dr Yeatman said.
Oncology Community Centers the New Frontier of Clinical Trials
The Guardian Research Network was established based on the belief that community centers can solve many of the problems facing drug development, such as limited access to patients, lack of time, and challenges with data accuracy.
Dr Yeatman believes that the potential of oncology community centers has not yet been fully recognized by pharmaceutical companies as the “new frontier” for clinical trials enrollment.
“Pharma does not know how to engage the community, but the Guardian Research Network can open the door to the community, by enabling health systems to perform trials,” Dr Yeatman said.
Community centers face a unique set of issues when it comes to initiating clinical trials, including the large volumes of patients with cancer with fewer centralized resources, smaller support staff for clinical trials, and very busy physicians. Furthermore, research may not be a strong focus of the administration and is not recognized as a value driver, but it can be.
“We can make trial participation easy. We believe that research drives reputation, which drives patient value, and, in turn, quality in health systems,” Dr Yeatman said. “We know when we establish a good research program, the quality of care goes up across the entire institution.”
Changing the Clinical Trials System
Dr Yeatman and his team saw the need for new approaches to improve efficiencies for the community, and to transform the US clinical trials system. The Guardian Research Network uses electronic medical records (EMRs) and sophisticated data tools to identify patients who may be suitable for clinical trials within hours or minutes, rather than the days or months it takes the majority of contract research organizations to do the same with a manual approach.
A complex problem requires a comprehensive solution: the Guardian Research Network is partnering with health systems across the nation to democratize clinical trial access, he said.
They started by developing a nationwide network with all the health systems aligned under one legal construct. In addition, they built a database, allowing them to quickly and efficiently search for patient inclusion and exclusion criteria for clinical trial participation. Furthermore, they added natural language processing to allow users to quickly peruse the EMR.
They also established a central Institutional Review Board for the entire program and a central contracting approach, so it is “one-stop shopping” for pharmaceutical companies, Dr Yeatman added.
By leveraging the network’s size, data platform, and the centralized contracting approach, the network can attract the best clinical trial opportunities for each of its partners. “Right now it’s hard for a community center to compete for the most cutting-edge trials, but this will enable them to do that,” Dr Yeatman said.
Guardian Research Network
According to Dr Yeatman, the Guardian Research Network could bring great value to the clinical trials system in terms of quality, cost, and speed. It has a sustainable business model, with the ability to perform clinical trial matching and big data analytics, and as the dimensionality of its data set grows, so will its value. He noted that the Guardian Research Network and the national Cancer Moonshot initiative, which aims to catalyze new scientific breakthroughs and improve patient access and care, share the same goals and are fully aligned in their visions.
When it comes to attracting clinical trials to the community, there is power in numbers, according to Dr Yeatman. The Guardian Research Network is nonexclusive and requires no membership or ongoing fees. It comprises 5 health systems serving approximately 31,000 patients and nearly 80 hospital systems; their goal is to enroll 10% of the patients in community centers participating in the network by 2019.
“The most important thing for a site to possess is administrative interest and support for the value in ‘research driving reputation,’” said Dr Yeatman regarding optimal site characteristics.