The World Health Organization declared COVID-19 as a pandemic in March of 2020. Since that time, the virus has caused chaos in most countries around the globe, leading to social distancing and economic challenges. To combat the spread of the virus, reduce morbidity and mortality, and prevent the healthcare systems from collapsing, many governments have invested millions in research. So far, the coronavirus has remained durable and no effective treatment has been found. Even though there are many vaccine trials underway, most are in the preliminary stage and it may be a year or two before a viable vaccine will be available. 


However, there is a universal consensus among multidisciplinary clinicians that patients with cancer should continue to be offered proven and life-saving interventions despite the risk of COVID 19. In the field of oncology, the core component of care is the conduction of clinical trials to assess investigational treatments. However, over the past few months, the risk-benefit ratio for participating in clinical trials has been clouded by the pandemic.


When clinical trials evaluate novel chemotherapeutic agents, frequent testing and repeated hospital visits are necessary to ensure the safety of the participant, but there is no guarantee that in return the participants will have a therapeutic benefit. Also, there is always the risk for treatment-related adverse events, which are compounded by the risk of increased exposure to the virus (contagion), which may turn off both patients and physician referrals for participating in these trials. However, current data suggest that many patients with malignancies who have already been enrolled in the clinical trial have expressed a strong interest in continuing with the trial despite the heightened risks.


Exactly how COVID 19 has affected cancer research and clinical trials still needs to be determined, but early signs are that there has been a profound negative effect. Because of government-mandated social distancing and city wide lockdowns, many clinical and basic laboratories have temporarily shut down and numerous trials have been terminated or paused. During the last four months, recruitment for clinical trials has almost ceased and the running costs of having healthcare professionals/lab assessing participants remain very high.


Many ongoing oncology trials have been hampered by the COVID 19 pandemic and without good clinical data, oncologists often find it difficult to prescribe therapies, Without data-driven direction, it is the oncology patient who ultimately suffers. The COVID pandemic has sent a clear message - without clinical trials, it is the society at large that will suffer. The scientific community must raise the bar to find new and improved ways to conduct clinical trials in the present circumstances. The important point is not to use surrogate endpoints but instead use overall survival and quality of life when it comes to the evaluation of oncologic therapies.


Another thing to learn from the COVID-19 pandemic is that redundancy in studies needs to be limited. Investigators who are only studying drug combinations or potential drugs with no significant clinical value should not initiate a clinical trial to avoid wastage of resources. Since many aspects of medicine have gone virtual, this should be the next frontier for clinical trials. The ability to conduct virtual meetings and tumour board meetings with physicians across academic centers may be one avenue to conduct trials in this new world.


No one knows how long the COVID-19 pandemic will last and what further impact it will have on society. However, healthcare workers should learn from this experience and improve their clinical practice to become better physicians by incorporating new technologies so that patient outcomes improve.


Source: JAMA

Image Credit: iStock


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References:

Araujo DV, Watson GA, Siu LL (2020) The Day After COVID-19—Time to Rethink Oncology Clinical Research. JAMA Oncol. doi:10.1001/jamaoncol.2020.4240



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Oncology, cancer care, COVID-19, oncology clinical trials The Lingering Effects of COVID-19