By Tammy McCausland
As COVID-19 took hold, it upended almost everything in healthcare. It has changed how healthcare providers work and how patients receive their care. The media have reported on the increased use of telehealth, treatment delays and the impacts on clinical trials. Typically, according to the National Cancer Institute, approximately 3 to 5 percent of adult cancer patients participate in clinical trials.
A perspectives article published in Clinical Cancer Research in April outlines the challenges of continuing treatments for patients enrolled in clinical trials. The authors discuss new clinical trial practices specific to cancer.” A Cancer Network article about the editorial mentions “new risk assessment strategies, decentralized and remote trial coordination, data collection, and delegation of specific therapeutic activities.”
In a recent guest editorial published in The Cancer Letter, three oncologists from the Helen F. Graham Cancer Center & Research Institute write, “Recent data from the Alliance for Clinical Trials in Oncology suggests that clinical trial enrollment may be down 40% to 60% across the country due to these new, unique challenges.” They explain that with more patients being seen by telehealth, it’s difficult to fully explain clinical trials and to identify suitable clinical trial candidates. At the same time, telehealth offers new opportunities, such as having shorter visits that can include chances to explain a clinical trial. The authors explain how their institute remains committed to sustained clinical trial accrual.
Clinical research at Dana-Farber Cancer Institute also remains on track thanks to “technological and procedural workarounds.” Meetings between cancer patients and their cancer research teams occur largely via teleconference to allow for frequent contact. Blood tests, as well as CT and other scans, are done outside the Institute. New restrictions have limited the enrollment of patients on new trials, especially for trials that require research biopsies; however, investigators continue to identify candidates to enroll once the restrictions are lifted.
New clinical trials are underway to explore the use of immunotherapy drugs to help cancer patients fighting COVID-19. For example, the Food and Drug Administration (FDA) approved a clinical trial at Roswell Park Comprehensive Cancer Center to test how a combination of rintatolimod and interferon alfa can help cancer patients who are also fighting COVID-19. Cancer patients receive immunotherapy drugs to boost their immune system.
The University of Oklahoma Medicine’s Stephenson Cancer Center will conduct two clinical trials related to cancer patients and COVID-19. One clinical trial will follow enrollees for two years and gather data about their health with cancer, COVID-19 and other medical tests. The second trial will focus on tocilizumab, a drug cancer used to treat patients whose immune systems have become overstimulated. Researchers will study “how tocilizumab effects cancer patients who are also infected by COVID-19 and are experiencing respiratory distress.”
Researchers at Memorial Sloan Kettering (MSK) have also launched a Phase II clinical study “to see if the drug tocilizumab can prevent respiratory failure in patients with severe COVID-19 infection.” MSK recently published “The Many Faces of the Immune Response to COVID-19: How Cancer Research Is Contributing to a Deeper Understanding,” an article that details how MSK researchers are applying their immunology knowledge to develop treatments for COVID-19.
Degarelix, a drug approved by the FDA in 2008 to treat advanced prostate cancer, may have the potential to treat COVID-19 in men. The U.S. Department of Veterans Affairs (VA) started a clinical trial to study degarelix “as a coronavirus treatment because testosterone is also believed to aid in the production of the protein TMPRSS2 in lung tissue, which the virus uses to penetrate lung cells.”
These are but a few examples of ongoing clinical trials and research efforts to study COVID-19. While COVID-19 has wreaked havoc and disruption, it’s not all bad news. Recent news about clinical trials suggests possible upsides––namely, an abundance of data and research that may help advance treatments for COVID-19, and new protocols or best practices that could make future cancer clinical trials more feasible and cost-effective.
How has your department handled clinical trials? Share best practices or lessons learned.