For people with cancer — further evidence of worse outcomes due to COVID-19

thomasbrown

By Thomas Brown, MD

09/17/2020

Syapse and the FDA are Using Real-World Data to Better Understand COVID-19 in Cancer Patients

Cancer is an insidious disease. It is relentless even in the face of a global pandemic. Dr. Ned Sharpless, director of the National Cancer Institute, recently shared that delays due to COVID-19 in screening, diagnosis and treatment, are likely to contribute to a rise in cancer deaths — over 10,000 more in patients with breast and colorectal cancers in the next decade. In my work with our health system partners, we saw a decline in genomic testing during the early period of COVID-19 using our dynamic and real-time tools, and used these insights to support oncologists in leveraging the use of precision medicine. Based on this work, Dr. Sharpless’ numbers may be conservative and as a medical oncologist dedicated to developing new cancer therapies to prolong patients’ lives, this is new territory as we consider how to provide care under quarantine, social distancing, and the like.  

Our work at Syapse focuses on how we can leverage real-world data (RWD) and evidence (RWE) to address healthcare challenges, specifically in the context of improving cancer care through precision medicine. Researchers using RWD are in the fortunate position to be able to track the cancer patient’s journey from pre- to post-diagnosis and beyond. This can lead to a less costly, and more comprehensive, understanding of product efficacy and safety required by payers, providers, and regulators for approval. Using real-world data can power public health and clinical trial enrollment programs, and help us understand the impact of COVID-19 on patients with cancer. This novel disease is filled with the unknown, and in partnership with the FDA, we are compelled to focus our resources on better understanding which patients with cancer are at the highest COVID-19 risk and potentially face fatal outcomes. 

In the summer of 2019, Syapse entered into a 4-year Research Collaboration Agreement with the FDA Oncology Center of Excellence to define standards for how to utilize RWD/RWE to support regulatory decision-making, policies, and novel collaborative research. We recently announced an expansion of this agreement to allow for collaboration in addressing urgent healthcare challenges, such as the current pandemic. In partnership with our health system partners within the Syapse Learning Health NetworkTM (SLHN), we evaluated the impact of COVID-19 on patients with active cancer or patients with a past history of cancer. We are not alone in this work and our recent findings are consistent with what we are seeing across the healthcare industry. 

Our recent study* suggests an increased risk of COVID-19: Amongst Black Americans, and patients with lower incomes. We observed that Patients with cancer and COVID-19 had an increased risk of severe complications from the virus, especially for patients undergoing active cancer management.  We plan to expand this analysis with additional health systems within the SLHN to assess acute complications with COVID-19, explore the impact of anti-cancer therapies and accepted anti-COVID-19 therapies, along with the long-term implications of COVID-19.

Evidence of healthcare disparities in the diagnosis and treatment of COVID-19 is not surprising. These disparities across race and socioeconomic status become more pronounced during a pandemic. We can only hope that this tragedy motivates us to improve access to care for all Americans and as Dr. Sharpless’ comments underscore, this should include timely interventions for cancer screening, early detection and treatment. Our work demonstrates the value of RWD and RWE to address valid research questions that almost by definition fall out of the construct of prospective cancer clinical trials, which already show a low number of participants from underserved populations.  

We are committed to using RWD and RWE in our work with health systems, life sciences companies and regulators to support clinical and regulatory decision-making, improve clinical trial enrollment, and investigate promising ways to support clinicians and their cancer patients during this trying time. 

Wishing you good health,

Dr. Brown