The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials

Abstract

Purpose of review The COVID-19 pandemic has had a devastating impact on virtually all aspects of the healthcare system, including oncology clinical trials. The purpose of this review is to describe the impact of the pandemic on national breast cancer clinical trials. Recent findings Of the 61 breast cancer–specific cooperative group breast cancer clinical trials open to accrual during the pandemic, 32% of them received supplementary tailored guidance regarding current and foreseeable challenges for clinical sites and investigators due to COVID-19. Many clinical trial sites reported decreases in enrollment and accrual, drastic disruptions to protocol, and challenges related to research infrastructure, staff burden, and assuring social distancing. Summary The challenges early in pandemic led to many operational changes in clinical trials, including use of electronic consent for enrollment, telemedicine visits, and mail order pharmacy. The pandemic highlighted aspects of breast cancer clinical trial that could be modernized while maintaining research integrity.

Telehealth adoption in cancer clinical trials: An Australian perspective

“…42 A lack of telehealth training (for both staff and consumers) has been identified as a major barrier to efficient implementation and contributes to poor data quality. 15,20,[43][44][45][46][47][48] A recent study corroborated our findings and addressed this impediment, by highlighting the need for proactive training using standardized and evidence-based methods in other areas of cancer care. 49 However, our emphasis on community-based learning as a critical tool to strengthen skills and educate oncological clinical trial staff is novel.…”

“…This framework emphasized the need for engagement of stakeholders in the development of guidelines, training protocols, and technologies in relation to virtual aspects of a trial such as remote monitoring 42 . A lack of telehealth training (for both staff and consumers) has been identified as a major barrier to efficient implementation and contributes to poor data quality 15,20,43–48 . A recent study corroborated our findings and addressed this impediment, by highlighting the need for proactive training using standardized and evidence‐based methods in other areas of cancer care 49 .…”

“…As such, COVID-19 facilitated telehealth uptake because it was a viable way of maintaining clinical trials, patient safety and access. [15][16][17][18][19][20][21][22] Examples of telehealth services in clinical trials include: virtual explanation of study procedures and patient support, obtaining consent remotely (e-Consent), and video/telephone appointments between trial staff and participants.…”

“…Consequently, clinical trials (like all aspects of cancer care) adopted alternate models of delivery to mitigate risk of infection among a vulnerable and immunocompromised population. As such, COVID‐19 facilitated telehealth uptake because it was a viable way of maintaining clinical trials, patient safety and access 15–22 . Examples of telehealth services in clinical trials include: virtual explanation of study procedures and patient support, obtaining consent remotely (e‐Consent), and video/telephone appointments between trial staff and participants.…”

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

“…Several reports have described the deleterious effect of the pandemic on cancer clinical trial participation at individual academic institutions or NCI National Clinical Trials Network (NCTN) groups. 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 .…”