Abstract
A partnership between the FDA and the American Society of Clinical Oncology's CancerLinQ provides regulators with timely, real-world data on newly approved cancer therapies. The alliance may help investigators gain insights and assess the impact of drugs in patient populations that are not well represented in traditional clinical trials.
A new partnership between the FDA and CancerLinQ—the big data initiative launched by the American Society of Clinical Oncology (ASCO)—equips the federal agency with timely, real-world patient data to help its regulators quickly assess the impact of newly approved cancer therapies. The FDA hopes the data will offer insights into cancer treatments beyond what is learned through traditional clinical trials.
“We will explore a variety of issues, including the optimal sequence of treatments, the impact that other health problems have on treatment tolerability and cancer outcomes, and the experience with immunotherapy combinations versus single agents,” says Sean Khozin, MD, MPH, the FDA's acting associate director for oncology regulatory science and informatics in the Oncology Center of Excellence (OCE). Investigators will initially focus on advanced melanoma and eventually delve into other cancers, he adds.
Data from CancerLinQ enables investigators to identify patterns of care across cancer types and therapies in all types of patients, says CancerLinQ's CEO Kevin Fitzpatrick. It provides critical information about how therapies work in specific populations that are not traditionally well represented in clinical trials, such as elderly patients.
“If you look at studies related to breast cancer, for example, there are not many patients age 65 or older enrolled, yet the greatest incidence of cancer in the United States is in that age range,” he says. “That's a primary difficulty we're trying to overcome and an example of what the FDA sees as a great potential efficacy of the CancerLinQ dataset.”
CancerLinQ also provides valuable data about patients excluded from clinical trials due to issues such as poor performance status, brain metastasis, HIV, or history of prior malignancies, says Khozin. For example, relatively little is known about the risks and potential benefits for patients with a history of autoimmune disease who receive checkpoint inhibitors.
“This partnership allows us to serve as a real-world source of data on patients as they receive care from the health system, when and where it happens,” says Jennifer L. Wong, MPP, CancerLinQ's chief of strategic alliances. “Taking a patient-centric approach and providing access to relevant and representative data, we have welcomed FDA and other collaborators to work with us to understand what happens to patients—addressing gaps in the knowledge base, generating new evidence and, ultimately, enabling better informed decisions to practice better medicine.”
“Initially, we will provide FDA with data assessing the current status of clinical therapies to potentially update existing drug labels,” Wong continues. “In the long term, we plan to work together to see how these data could be used to potentially change or improve the review process for new drugs.”
The CancerLinQ collaboration is part of a growing portfolio of projects under the OCE's Information Exchange and Data Transformation program, says Khozin.
“We are pursuing multiple efforts to leverage technology and advanced analytics to help modernize clinical evidence generation,” Khozin says. “Real-world data from electronic health records and patient-generated sources, such as mobile applications and sensors, are key components of this effort—all aimed at increasing our understanding of the patients' experience.” –Janet Colwell