National Clinical Trials Networkbiobanking during the COVID-19 pandemic

ABSTRACT

The National Cancer Institute (NCI) has a large portfolio of ongoing cancer clinical trials that involve biospecimencollection and are supported by the NCI-funded National Clinical Trials Network (NCTN) Biospecimen Banks locatedacross the United States and Canada. At the start of the COVID-19 pandemic, NCTN biobanks rapidly responded tostaffing consequences of state- and institution-issued stay-at-home orders. Many of the NCTN biobanks weredeemed essential by their institutions, allowing for limited and/or socially distanced operations. NCTN biobanksquickly worked with NCI and their respective groups to advise participating sites of changes to usual biospecimencollection procedures in order to accommodate limited staffing at the biobanks. In many instances, participating sites were navigating their own institutional process change due to the pandemic. NCTN cancer clinical trials experiencedan approximate 40% decrease in enrollment from March 11 to May 19, 2020, compared to the same time frame in2019. Likewise, NCTN biobanks saw an approximate 40% and 60% decrease in biospecimen receipt anddistribution, respectively. The decrease in biospecimen receipt was likely due to two factors (1) participating siteCOVID-19 policies limiting patient enrollment on NCI cancer clinical trials and/or biospecimen collection for thosetrials, and (2) NCTN biobank requests for participating sites to hold nonurgent and/or nonmandatory biospecimensduring the initial phase of the pandemic. Decrease in biospecimen distributions was mainly due to receivinglaboratory closures as dictated by their institutional COVID-19 policies. On May 20, 2020, all states had begun initialreopening phases to some extent. At this time, several, but not all, NCTN biobanks had begun measured return tofull operations, following institutional guidance. NCTN biobanks are making numerous considerations towardreturning to full operations and will continue to work with NCI and their respective groups to responsibly collect anddistribute biospecimens collected during the COVID-19 pandemic. Likely, some patients enrolled on NCTN cancerclinical trials may have had clinical or subclinical COVID-19 at the time of biospecimen collection. Additionally, biospecimens will be collected on two recently activated NCI COVID-19 studies (1) the NCI COVID-19 in CancerPatients Study (NCCAPS) A Longitudinal Natural History Study ( NCT04387656 ), and (2) a tocilizumab treatmenttrial for COVID-19-related acute respiratory distress syndrome in cancer patients ( NCT04370834 ). Retrospectiveannotation of these biospecimens may provide a unique resource for translational research efforts and will also be aneeded caveat for interpreting biomarker studies conducted using these biospecimens, as the impact of COVID-19on various biomarkers is currently unknown.