Collateral damage of COVID-19 pandemic on oncology clinical trials.

Over the past decades, tremendous advancements in cancer care have translated into a substantial decline in disease-specific mortality rates (1,2). As the physicians and researchers continue to work on improving the cancerrelated mortality, we are hindered by the global pandemic coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite the fact that clinical trials are integral part of cancer care delivery that translated to decreased mortality (3), institutions across the globe temporarily halted clinical trial enrollment. There are many unanswered questions now: how long can we postpone enrollment of new individuals with cancer onto clinical trials? There is a fair chance that a considerable number of individuals may never be eligible for participation in clinical trials if their cancer progresses in the interim. In fact, some of the clinical trials have restrictions on prior lines of anticancer treatment and patients’ eligibility may be hampered by receipt of the standard of care therapies. The impact of such policies is not yet known, and is impossible to predict at this early time-point, but are likely to be substantial. Although halting the enrollment onto clinical trials is for public safety, it may not be welcoming news for the individuals with cancer, their families, and to the field of oncology. For the majority of patients with cancer, the priority remains the treatment of their underlying malignancy. If patients receive suboptimal therapy for their malignancy, there could be an increase in deaths indirectly related to the effects of COVID-19. Fortunately, many institutions across the globe are in the process of opening up clinical trials as medical facilities are adapting to this “new normal” health care delivery. In the early days of the pandemic, there was a critical need for volunteers among the health care workers that led to shifting the majority of the workforce to the front lines taking care of patients with COVID-19. While the pandemic has crossed the peak at some parts of the globe, health care professionals and medical researchers have worked on placing new protocols in place for better safety of health care workers and patients visiting medical facilities. It is most likely the case that hospitals are able to handle the COVID-19 challenges better compared to a couple of months ago. Herein we discuss some potential solutions that could potentiate the early opening of clinical trial options for oncology patients (Table 1). For any patient who chooses to participate in a clinical trial, SARS-CoV-2 antigen testing using a reverse transcription polymerized chain reaction (rtPCR) technique should be offered at the beginning of a clinical trial and prior to every cycle, especially while receiving immunosuppressive agents that have high propensity to cause neutropenia. The choice of the primer used in rtPCR assay is country specific. For instance, in the United States the standard practice is testing for three targets in nucleocapsid protein (N) of the virus genome whereas Germany uses envelop (E) and N proteins (4). The rtPCR testing should be offered to asymptomatic patients too as a recent single-institution study showed 8% of cancer patients had a positive SARS-CoV-2 PCR test before they developed symptomatic COVID-19 (5). It is important to note that mutations occur frequently in SARSCoV-2 and this could potentially cause false negatives in the diagnosis of COVID-19. The sensitivity of the rtPCR test may be increased by evaluating >1 proteins in the viral genome. Though there are no specific consensus Letter to the Editor