NCI statement on clinical trials during COVID-19 pandemic
Cancer patients are particularly vulnerable to infectious diseases such as COVID-19, both because of their underlying health condition and because cancer treatments can suppress the immune system. At this time, we do not know how the COVID-19 pandemic will evolve or the extent to which it will place stress on cancer patients, their families, and their caregivers.
The Centers for Disease Control and Prevention and other public health experts have provided authoritative advice on how individuals can protect themselves. Patients should seek advice from their health care providers regarding their individual care and whether they should be tested for COVID-19.
A patient's health care team is best suited to evaluate that individual's unique situation and advise on the safest course of action. As more information becomes available on mitigation strategies from physicians caring directly for cancer patients, that information will be shared broadly in the oncology community. For example, researchers at the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington have published information about managing cancer care during the COVID-19 pandemic, and NCI is closely monitoring the clinical experience of cancer caregivers across the world.
For individuals undergoing treatment for cancer, the spectrum of acute need for cancer treatment is broad. In some situations, it is essential that patients receive treatment immediately for their cancer. In other situations, such as for patients who are not receiving active treatment, visits for follow-up cancer care may be safely delayed. Patients should discuss individual treatment plans with their health care team.
During the challenging situation of the COVID-19 pandemic, we understand that health care system resources will be limited, and this may affect cancer clinical trial operations. We do, however, believe that there are circumstances (e.g., in order to access potentially life-saving therapy) where patients with cancer should enroll or continue to participate in a clinical trial. Advice given to patients participating in clinical trials should be tailored to the individual patient based on their clinical circumstances.
On March 18, the Food and Drug Administration issued guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic. In addition, NCI has provided guidance for clinical trials’ activities during the COVID-19 pandemic, with the intent of giving greater flexibility to the patient and their caregiver so that they may more easily be treated on a clinical trial if indicated.
We continue to closely monitor NCI-supported clinical trials to help address the needs of investigators to implement accommodations so that they can, to the greatest extent possible, maintain continuity of care for their patients who are being treated on trials. If a clinical trials site's policies and practices vary from the guidance we have outlined, they are encouraged to contact NCI’s Cancer Therapy Evaluation Program.