Cancer Research: A Silent Victim

33 views 1 05/17/2020

  1. COVID-19 has imposed serious and disruptive effects on hematology and oncology clinical trials, as thousands of cancer laboratories and clinical trials closed due to pandemic.1,2,3,4
  2. Immediate consequences are already seen:
    • Research staff and resources have been reassigned to manage the rush of patients at many academic institutions, therefore routine clinical research activities have been suspended.1,3,4 
    • While some institutions are still allowing research with the maintenance of the most irreplaceable cells or other time-sensitive experiments, others had to stop all experiments, including euthanizing entire colonies of mice.3 Some of these experiments might take years to generate again.3
    • Some patients are switched back to standard-of-care therapies to minimize the need of extra monitoring (lab, follow-up visits).3
    • Research-related appointments to hospitals (as for site selection, qualification, data verification, drug accountability, audit or staff training) by contract research organization and sponsors have been cancelled due to travel restrictions.1
    • Delays can be anticipated in data entry into clinical trial databases, as most of study coordinators are working remotely with reduced access to the source data.1,3
    • Most of protocol-mandated visits or study procedures have been cancelled. Delays in imaging study or laboratories monitoring required for some clinical trials are also noted.1,3,4
    • Trials testing treatments for COVID-19 have been prioritized 1, and some common cancer drugs are being investigated as a potential COVID-19 treatment. As for example, Chinese trials are assessing the role of Bevacizumab, Thalidomide and Camrelizumab in the treatments of SARS-CV-2 infections. JAK inhibitors are also gaining popularity.2 
  3. Delayed consequences are anticipated:
    • Recruitments delays resulting from pandemic will most likely affect drug development, with impact on financial implications of pharmaceutical and therefore a potential delay in getting promising drugs to patients.1,3
    • Many labs will spend their remaining funds to get back to where they were 1-2 years ago rather than making new discoveries.3
    • Protocol deviations are expected to occur during the pandemic and data will need to be carefully analysed.1 Moreover, COVID-19 related deaths could potentially affect survival endpoints in some studies.1
  4. Regulatory agencies (eg, US Food and Drug Administration, European Medicines Agency) have published guidelines on managing clinical trials throughout this pandemic, stressing the importance of pragmatism and flexibility.1,2,4  Many programs are modifying their approach in hope to prevent exposure to patient and staff and comply with regulations and public health guidance.4
  5. A survey showed that most institutions developed policies related to the pandemic, such as symptom-based screening strategies, telehealth visits and remote work. Most of the institutions also developed prioritizing strategies based on patients needs, safety and disease severity. On the other hand, most of the institutions reported a decrease in patient ability or willingness to come to their site as well as limited ancillary services.4
  6. Nevertheless, clinical trials are crucial and physicians need to keep in mind three considerations: 1- non-abandonment of a patient whose prognosis and wellbeing is likely dependent on an investigational treatment, 2- flatten the curve by minimizing any unnecessary exposure, and 3- emphasize on psychosocial support of the patient and of the research team in the middle of the outbreak.2,4

 

Sources:

  1. Saini S.K, Heras B.D.L., Castro J., Venkitaraman R, Poelman M., Srinivasan G., et al. (April 24, 2020). Effect of the COVID-19 Pandemic on cancer treatment and research. The Lancet Haematology. DOI: https://doi.org/10.1016/S2352-3026(20)30123-X
  2. Moujaess E., Kourie H.R, Ghosn M. (April 22, 2020). Cancer patients and research during COVID-19 pandemic: A systematic review of current evidence. Critical Reviews in Oncology/Hematology, DOI: 1016/j.critrevonc.2020.102972
  3. Colbert E.L., Kouzy R., Jaoude J.A., Ludmir E.B., Taniguchi C.M. (May 11, 2020). Cancer Research after COVID-19: Where Do We Go from Here? Cancer cell. https://doi.org/10.1016/j.ccell.2020.04.003
  4. Waterhouse D.M., Harvey R.D., Hurley P., Levit L.A., Kim E.S., Keplin H.D., et al. (May 12, 2020). Early Impact of COVID-19 on the conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings from an American Society of Clinical Oncology Survey. JCO Oncology Practice. DOI: 10.1200/OP.20.00275, https://ascopubs.org/doi/full/10.1200/OP.20.00275
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