The American Society of Clinical Oncology and Friends of Cancer Research have called on sponsors to begin including cancer patients in their COVID-19 vaccine trials unless there’s a potential safety risk.

According to the groups, COVID-19 vaccine trials have thus far “almost universally excluded” patients receiving treatment for cancer, while a large number have excluded patients with a history of cancer or those older than 65. Some trial exclusion criteria disqualified patients if they had a history of cancer (except nonmelanoma skin cancers), received cytotoxic or immune-modulating treatment in the past six months, or received systemic corticosteroids, they said.

Current federal guidelines recommend that patients across the cancer spectrum receive COVID-19 vaccinations unless there’s a possible risk to patient safety, but their recommendations are backed by expert consensus, not actual clinical evidence, according to the advocacy groups.

“Narrower, more homogenous patient populations may have been preferable in early-stage vaccine development to avoid compromising approval of potentially viable therapies. However, with multiple vaccines authorized for emergency use by the FDA and other national entities, as well as growing data on the safety profile of novel vaccines, eligibility should be expanded to include patients with cancer, a history of cancer and cancer-related immunologic deficiencies,” they said.

Before the pandemic, the groups were already engaged in similar work to expand and modernize cancer research eligibility criteria with the end goal of making trials more accessible to patients. For example, the pair assembled a working group to examine eligibility criteria for cancer trials, looking at criteria such as brain metastases, minimum age requirements, HIV/AIDS status, organ dysfunction and prior and current malignancies.