Strategies for avoiding abandonment of patients participating in cancer clinical trials during the COVID-19 pandemic while also providing emotional support to this vulnerable population and maintaining approaches to “flatten the curve” of COVID-19 infection are summarized by the medical ethics editorial team of The Oncologist.1
Factors that make patients with cancer a particularly vulnerable population often include older age, multiple comorbidities, increased susceptibility to infections, and more severe consequences associated with those infections, including infection with COVID-19. For patients with cancer currently participating in clinical trials, the increased likelihood of clinical research staff being diverted to other roles during the COVID-19 crisis further compounds this vulnerability.
Recognizing that the delivery of cancer care within the context of a clinical trial is likely to evolve during this crisis, the editorial authors, Andrew G. Shuman, MD, of the Center for Bioethics & Social Sciences in Medicine and Rogel Cancer Center, University of Michigan Medical School in Ann Arbor, and Rebecca D. Pentz, PhD, of the Winship Cancer Institute, Emory School of Medicine in Atlanta, Georgia, stressed the importance of finding “creative delivery systems such as telehealth, home infusions, remote laboratories, and use of satellite facilities” to continue to provide clinical trial protocol-based therapy to patients enrolled in cancer clinical trials.
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At the same time, the authors of the editorial emphasized the necessity of following guidance from the Centers of Disease Control and Prevention (CDC) regarding the implementation of measures to limit the spread of COVID-19 among cancer clinical trial participants and clinical research staff. They also referred readers to recently issued documents from the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) regarding the management of potential protocol deviations resulting from the possible necessity of limiting in-person study visits.2,3
Finally, the importance of finding approaches to address the psychosocial impact associated with being both a research participant, as well as a patient undergoing cancer treatment during the COVID-19 pandemic, was stressed by Drs. Shuman and Pentz.
The editorial authors stated that “clinicians and researchers alike are behooved to consider how best to protect participants’ health and interests, and to support their collective well-being even during our most challenging moments.”
References
1. Shuman AG, Pentz RD. Cancer research ethics and COVID-19 [published online March 30, 2020]. Oncologist. doi:10.1634/theoncologist.2020-0221
2. Guidance for NIH-funded clinical trials and human subjects studies affected by COVID-19 [NIH notice]. National Institutes of Health; March 16, 2020. Accessed April 14, 2020. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html
3. FDA guidance on conduct of clinical trials of medical products during COVID-19 pandemic [guidance document]. US Food & Drug Administration. Updated March 27, 2020. Accessed April 14, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic
