The launch comes as major cancer research organizations are calling for ways to increase diversity in clinical trials.
The OneOncology network of independent oncology practices today announced it had formed a subsidiary focused on clinical trial site management, designed to give community practices and their patients access to the most cutting-edge therapies.
Called the OneOncology Research Network, or OneR, the entity will be a non-exclusive clinical trail site management organization (SMO), offering operational, regulatory, and research support services. The mission is to let multicenter trials take place seamlessly, with a structure that gives patients access to research within and beyond the OneR network.
“OneR is a community oncology network designed for and built by community oncology practices,” Lee Schwartzberg, MD, chief medical officer for OneOncology and medical director for West Cancer Center of Memphis, Tennessee, said in a statement.
“Our north star is improving the lives of everyone with cancer which is fundamentally dependent on advancing the science of oncology treatments,” he said. “We look forward to working with practices and sponsors who want to expand diverse patient access to precision oncology and other high-quality cancer clinical trials through our portfolio of therapeutic and observational studies.”
The need for better support for clinical trials at the community level stems from the explosion of discovery in cancer treatment. At the same time, both the FDA and research groups have asked whether new therapies are meeting the needs of an aging and increasingly diverse population.
In 2012, Congress called on FDA to start tracking how well the participation in drug trials tracks the US population overall. A 2017 report by FDA, based on global trial data from 2015-2016, found that Black patients from the United States were underrepresented in oncology trials.
In recent months, several major cancer organizations have announced reports or initiatives to address this issue; in August, American Society for Clinical Oncology and the Association of Community Cancer Centers launched a collaboration to improve diversity in clinical trial participation.
Offering access to clinical trials at the community level will capture patients who might have felt going to an academic center for a study was financially impossible or just impractical. In a statement, the network said, “OneR provides clinical trial sponsors access to the large and diverse populations of patients who are treated in community centers throughout their cancer journey, and not episodic as is more common in research-based academic centers.”
The network envisions seeing broader diversity by ethnicity, gender, geography, disease status, socioeconomics “and various other dimensions,” the statement said.
The OneR structure will allow patients to access innovative trials designs, such as basket trials, which are based on seeing how a new drug works across multiple cancers all driven by the same biomarker or mutation. Another design, called umbrella trials, involves enrollment based on a molecular profile of a patient’s individual cancer.
This setup offers hope for patients who have too often been left out of studies for lack of insurance, comorbidities, or the inability to travel long distances.
“With too many of our patients disproportionately impacted by health disparities, we believe that by providing community oncology practices with enhanced operational efficiencies we can ensure that more patients will benefit from the groundbreaking clinical trials,” said Axel Grothey, MD, medical director, OneR and director, GI Cancer Research, West Cancer Center. “OneR will not only improve patient access to cutting-edge care, it will also help to advance scientific discovery.”