Clinical Research
Clinical oncology research trials in the era of COVID-19 can continue in
some instances and ethical guidance is available.11Shuman AG,
Pentz RD. Cancer Research Ethics and COVID-19. Oncologist. 2020
(Epub). Trials can be stratified by trial phase, disease
site/stage/histology, and treatment intent as well as how these options
would compare with clinical care off-trial. Trials with a high
likelihood of benefit should proceed although they may need modification
after consideration of the added burdens, risks, and trial-specific
testing and face-to-face interactions. For trials without clear benefits
to the participant, continued enrollment into the trial is viewed in the
context of the potential for generalizable knowledge afforded by the
data generated. For head & neck cancer specifically – in everything
from investigator-initiated to cooperative trials – risks, benefits and
tradeoffs should be assessed, knowing that every intervention and
instrumentation of the upper aerodigestive tract poses a risk to
patients, subjects, and providers alike.
Regulatory and funding agencies have provided resources to assist. The
NCI has issued specific guidance for federally funded cancer
trials,22NCI CIRB information about COVID-19.
https://www.ncicirb.org/content/nci-cirb-information-about-covid-19
Accessed 6 April 2020. and the NIH has broader resources available
for clinical researchers.33Guidance for NIH-funded Clincal
Trials and Human Subjects Studies Affected by COVID-19. 2020.
Available at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html.
Accessed March 17, 2020. In addition, specific FDA guidance will be
of value for those trials involving their regulatory
oversight.44FDA Guidance on Conduct of Clinical Trials of
Medical Products during COVID-19 Pandemic. 2020. Available at
https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/fda-guidance-conduct-clinical-trialsmedical-products-during-covid-19-pandemic?utm_source=&utm_medium=&utm_campaign=.
Accessed March 17, 2020.