Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic

Abstract

Introduction Clinical trial enrollment has declined globally due to the COVID-19 pandemic. This underscores the importance of structured methods to continue critical medical research safely and efficiently. Methods We report the impact of a phased trial reopening strategy, remote research staffing, and telemedicine on cancer trial enrollment at one of the largest Radiation Oncology academic cancer centers. In Phase 1, trials investigating definitive therapeutic benefit were opened, followed by trials not increasing patient exposure or pulmonary toxicity risk in Phase 2. During Phase 2.5, multicenter trials reopened and limited research staff were allowed on-site. Results Despite initial enrollment declines during the early pandemic, the percentage of new patients enrolling in clinical trials from March to August 2020 was 8.8%, and represented an 10.5% relative increase from 2019. Monthly accrual enrollment from March to August 2019 ranged from 42-71 compared to enrollment during COVID-19 from 23-73 patients (p<0.001). Conclusions Through a phased approach to trial reopening and adaptive techniques, the Division of Radiation Oncology maintained cancer trial accrual during the COVID-19 pandemic. The experience may help centers maintain accrual, preserve clinical trial integrity, and minimize risk to patients and staff.

Patterns of Enrollment in Cancer Treatment Trials During the COVID-19 Pandemic at National Cancer Institute–Designated Cancer Centers

“…Our findings are consistent with reports that some institutions initially prioritized national and later phase trials or those with potential for the greatest clinical benefit while minimizing correlative procedures. 3,6 Although there may be several reasons why enrollments have not fully recovered to prepandemic levels, staff turnover or a decrease in clinical trial staff due to reassignment of clinical trials research staff to other health care activities may be a contributing factor. Anecdotal reports from some NCI-DCCs and a recent blog from one of the NCTN groups support this notion.…”

“…Our findings are consistent with reports that some institutions initially prioritized national and later phase trials or those with potential for the greatest clinical benefit while minimizing correlative procedures. 3 , 6 …”

“…However, none have addressed the impact of the pandemic on enrollment to cancer treatment trials throughout NCI-Designated Cancer Centers (DCCs), a major component of the nation’s cancer research infrastructure. 3 – 6 There are currently 64 NCI-DCCs (51 comprehensive cancer centers and 13 clinical cancer centers) located in 35 states and the District of Columbia that are funded to deliver cutting-edge treatments and clinical trials to patients as part of their mission. 7 The purpose of this report is to describe the pattern of enrollment to cancer treatment trials at NCI-DCCs during the COVID-19 pandemic.…”

Impact of the COVID-19 Pandemic on Cancer Researchers in 2020: A Qualitative Study of Events to Inform Mitigation Strategies

“…Issues concerning the maintenance of trial administration during COVID-19 pressures are complex ( 11 ), particularly given that COVID-19 caused the disruption of clinical workforce management due to government orders to “stay at home”, restricted working hours, and the need for self-isolation due to a positive COVID-19 test (or contact with someone who tested positive). However, some centres have reported sustainable adaptations to the way they conduct cancer clinical trials, and successful maintenance of pre-pandemic accrual rates despite persistently challenging conditions ( 12 ). Such centres offer exemplary approaches for navigating clinical trials through the COVID-19 crisis (should the capacity for such adaptations exist locally).…”

Oncology During the COVID-19 Pandemic: a Lockdown Perspective

“…As infection control measures were implemented, oncology trials were largely halted. The world’s focus shifted away from cancer research, taking with it financial cutbacks by many academic institutions [ 59 ], a global reduction in patient enrolment in oncology trials [ 60 •] and stunting the activation of new trials [ 61 ]. These changes are particularly detrimental for patients with rare cancers or patients who have progressed on all available the treatment lines, who invest their hope in new experimental therapies where there is a lack of standard treatment options [ 2 •].…”