Considerations of Continuing Clinical Trials During the COVID-19 Pandemic

Kathleen N. Moore, MD, from the University of Oklahoma Stephenson Cancer Center, gives a brief talk on considerations of continuing clinical trial participation during the COVID-19 pandemic, while acknowledging every situation is different based on geographic location and decisions made at the institutional level.

Key Points:

• The health and care of our patients diagnosed with cancer is always the center of what we do as oncologists—COVID or no COVID.
• Patients with cancer may be particularly vulnerable to infectious diseases, such as COVID-19, both because of underlying conditions or potential influences of their cancer therapies.
• Clinical trials are part of best practices for cancer treatment and, in some cases, offer patients access to potentially life-saving or life-extending therapies not otherwise available.
• The COVID-19 pandemic challenges the capability to maintain clinical trial availability in certain parts of the country where resources were shifted to other areas of the health care system or clinical research staff are instructed to shelter in place to avoid exposure.
• Where trials are still available, attention should be paid to offering trials to patients without other effective treatment options at this time, offering trial treatments that do not inordinately place patients at higher than normal risk for immunosuppression or infection, and assessing whether your site can maintain GCP and trial integrity given the challenges with staffing and potential over-exposure to the clinical setting for trial participants.
• If possible, patients currently participating in clinical research should be offered the opportunity to continue if GCP and data integrity can be maintained ONLY if the study treatment isn’t placing them at higher than normal risk for immunosuppression or infection. In these later cases, discuss with the treatment team on the best plan for each individual.