COVID and the Cancer Moonshot

Recently, President Biden reignited the Cancer Moonshot initiative, with a goal of reducing the death rate from cancer by at least 50 percent over the next 25 years. This call to action includes a focus on cancer screening and early detection, given the more than 9.5 million missed cancer screenings in the United States resulting from the COVID-19 pandemic, and on new cancer therapies.

An equally worrisome consequence of the pandemic, though, has been the paucity of patients enrolling to cancer clinical trials, which could delay by years the introduction of those exciting new treatments or cancer prevention strategies referred to in the administration’s initiative — the drugs that could help reduce the cancer death rate.

Not long ago I saw a patient, a man in his 60s, who had been diagnosed with acute leukemia. He sat in my clinic room alone, with his daughter on the phone listening: At the height of the omicron COVID-19 surge our cancer center, like many others, was not allowing visitors to accompany patients.

After the first course of chemotherapy failed him months earlier, we tried a second. When that proved futile, we had few treatment options remaining — and none that offered a chance that his leukemia would go into a remission much above 20 percent.

We had reached that point in the conversation when I start to broach palliative care with my patients. 

“How about a clinical trial?” He asked, his eyes beseeching me above his mask. His daughter echoed the question from his phone. He told me that he wanted to continue to aggressively treat his leukemia.

I paused before answering. We certainly had clinical trials available for people with a leukemia, like his, that refused to be extinguished. And he would probably qualify for one.

The problem was that clinical trials had been placed on hold at my institution because so many of our research coordinators were either out sick with COVID-19 infections or had quit their jobs during the pandemic. We simply didn’t have enough people to ensure the proper conduct and regulatory compliance of these studies, so we stopped offering the trials to patients.

Our cancer center is not alone. I have also conducted clinical research for two decades, and this past year I designed a clinical trial for people with a type of bone marrow cancer — myelodysplastic syndromes — that is similar to leukemia. The trial will be opened at multiple National Cancer Institute comprehensive cancer centers. When I provided the study protocol to one center that had agreed to participate, an investigator there informed me it would take a year to open the trial because their research coordinators had also left in droves. Two other centers replied similarly, citing a lack of research nurses.  

We have a crisis in cancer research staffing stemming, in part, from the great resignation of the pandemic or employee illness, and have to choose between delaying the opening of new clinical trials; closing trials altogether; or continuing to offer trials but without the same level of supervision, which could compromise the safety of patients. 

One analysis reported a 60 percent decrease in the launching of new clinical trials for cancer drugs and biologic therapies during the first wave of the pandemic. Another study reported a 9 percent weekly reduction in enrollments during the first COVID-19 wave, and a more modest dip in patient accrual to clinical trials during the 2020 to 2021 wave. Cancer control and prevention trials took the greatest hit in patient accrual, with an almost 50 percent reduction.

There are a number of reasons enrollment to cancer trials was compromised. Some trials, like mine, had delays in opening because of cancer center staffing. Others were closed out of fear that patients with cancers that affected the immune system — like leukemia or lymphoma — or of the lungs would be at higher risk of dying if they were also infected with COVID-19, and that the death could erroneously be attributed to the study medication. At my previous institution, almost 10 percent of all cancer clinical trials were suspended in 2020, but that number rose to 25 percent for trials enrolling patients with blood or bone marrow cancers. Some patients were hesitant to enroll in studies that might require more contact with the health care system during pandemic surges than they would have needed with standard treatments. And some study sponsors of trials were slow to adapt to the new reality of clinical research in the pandemic, continuing to require, for example, in-person study monitoring when cancer centers weren’t even allowing family members of cancer patients to be present.

Patients enroll in cancer clinical trials for a variety of reasons, from wanting to receive direct medical benefit themselves from the study medications, to maintaining hope and even altruism — helping future patients. It can take years from when an Investigational New Drug (IND) application is first filed with the Food and Drug Administration (what is required to conduct a clinical trial) to when a New Drug Application (NDA) is submitted for that drug’s approval — even for the so-called targeted cancer treatments highlighted in the Cancer Moonshot initiative.

I worry that the delays in cancer clinical trial enrollment we are experiencing today will have a negative impact on the cancer patients I will be treating years from now.

To help ensure the success of the Cancer Moonshot program, we need to change the way we conduct cancer clinical trials and make them impervious to future pandemic surges. Clinical trials should remove obstacles for patient participation by offering studies in community settings, where patients live and by eliminating extra visits: incorporating telemedicine for study requirements such as obtaining informed consent, as well as shipping medications directly to a patient’s home. Study staff should work remotely and monitoring conducted similarly, to reduce the spread of infection and allow staff to work where they live, to enhance their retention. And trials should be designed to allow patients to enroll irrespective of the presence of a pandemic, because we’ll need to treat patients’ cancers when they arise, and not when it’s convenient.

For my patient, I was able to cobble together a chemotherapy regimen to keep his leukemia at bay for a few weeks, when our clinical trials reopened with the return to health of research staff and hiring of new staff. He did enroll on a study of an experimental drug — and his leukemia went into a remission.

He’s doing well, and we’re both cautiously optimistic — about his future, and the future of cancer therapy.

Mikkael A. Sekeres, MD, MS is chief of the Division of Hematology and professor of medicine at the Sylvester Comprehensive Cancer Center, University of Miami. He is the author of “When Blood Breaks Down: Life Lessons From Leukemia” (The MIT Press 2020) and of the forthcoming book “Drugs and the FDA: Safety, Efficacy, and the Public’s Trust” (The MIT Press 2022). Follow him on Twitter: @MikkaelSekeres