Globally, Cancer is a life-threatening disease, and, to many patients, specifically in developing countries, participation in clinical trials helps them to receive treatment. The COVID-19 pandemic has brought a large amount of uncertainty and challenges to both oncologists and cancer patients and added an additional burden to existing cancer treatment / clinical trials.
Oncology patients have been heavily impacted including delays in receiving initial diagnosis due to overwhelmed health systems, and potential disruption to their drug supplies. Cancer patients are often at higher risk of infection due to less/no immunity and also have co-morbidities and hence have a greater need to isolate as a vulnerable person.
COVID-19 has changed the international health care system in every single way including the running of oncology clinical trials, which have suffered with a higher rate of disruption than other research. For example, the use of telehealth has played a vital role between patients and physicians allowing traditional treatment and clinical trials to continue. However, for cancer patients existing telehealth needs to be modified as oncologists often rely on visual signals such as how a patient moves or whether they indicate pain, which could be missed online.
In general, cancer patients would be classified under Maintenance Therapy, Activity Therapy and those being planned for the treatment. Clinical judgment is paramount in determining whether to continue or withhold cancer therapy based on their therapy classification in patients with suspected or confirmed COVID-19. The true effect of COVID-19 on cancer research has yet to be fully determined, but the early effects have been intense. As a consequence, ongoing and planned oncology clinical trials around the world have had temporary closure, delayed patient treatment or been terminated.
We are now seeing a new challenge for the patients and research. Patients undergoing treatment may be offered vaccination against COVID-19 if any components of the vaccine are not contraindicated. However as there is still uncertainty around the extent to which immunocompromised patients with cancer will develop immunity in response to vaccination, vaccinated patients should continue to follow current guidance to protect themselves from exposure to COVID-19.
There is currently a lack of vaccine efficacy and immunogenicity data, specifically in the cancer population. In this case, the use of adaptive trial design provides agility to the drug development process. Here, the advantage is that entire information can be used to adapt the trial without fully specifying the adaptation rule. Recent technology such as artificial intelligence (AI) or machine learning algorithms (ML) also provide better diagnosis treatments and care paths of cancer patients. Artificial Intelligence virtually eliminate human distraction and potential shortfalls caused by pandemics or other unknown factors.
This is crucial in the pandemic situation to go beyond the “research as usual” approach and transform our research via advance techniques such as Adaptive design, AI and ML tools to care the cancer patients and discover new and more effective treatments without compromising its integrity.