July 22, 2020
The following quote is attributed to Harpreet Singh, M.D., Associate Director, Cancer in Older Adults and Special Populations, FDA’s Oncology Center of Excellence; and Director, Division of Oncology 2, FDA’s Center for Drug Evaluation and Research:
“The clinical experience of people with cancer who have contracted COVID-19 is an essential resource that can help the medical community better understand the impact of the disease in this population.
“The data we analyzed in collaboration with Syapse revealed a stark reality that people with cancer are at an increased risk of more serious outcomes from COVID-19 but also that there are inequities for Black Americans and those of lower socioeconomic means. It’s imperative that we continue to rapidly examine real-world data to address the urgent health care challenges brought on by this pandemic.
“In OCE, we will continue to work diligently to meet the needs of cancer patients, who constitute a vulnerable population at risk of contracting COVID-19.”
- The FDA’s Oncology Center of Excellence (OCE) and Syapse presented data at the American Association of Clinical Research (AACR) COVID-19 and Cancer meeting on an analysis of more than 212,000 health records of people living with cancer across two major health systems in the Midwestern United States.
- The analysis found that cancer patients who also had COVID-19 are more likely (compared to those without COVID-19) to have: (1) other health conditions (e.g., kidney failure, obesity and heart disease), (2) increased rates of hospitalization and invasive mechanical ventilation, and (3) a 16-fold increased mortality risk. The researchers also underscored evidence for health care disparities among cancer patients with COVID-19.
- This presentation is part of OCE’s partnerships with experts in healthcare data and analytics to investigate characteristics and clinical outcomes of patients with cancer who are infected with SARS-CoV-2, the virus that causes COVID-19. This work builds upon several initiatives under way across FDA that leverage real-world data to improve understanding of COVID-19. These efforts include FDA’s participation in the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research.
- The OCE continues to engage with stakeholders and collaborate with partners on opportunities to apply data from diverse sources to inform its understanding of COVID-19 in people with cancer.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.