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.