Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical Oncology Survey

Abstract

<jats:p> The coronavirus disease 2019 (COVID-19) pandemic has disrupted all aspects of clinical care, including cancer clinical trials. In March 2020, ASCO launched a survey of clinical programs represented on its Cancer Research Committee and Research Community Forum Steering Group and taskforces to learn about the types of changes and challenges that clinical trial programs were experiencing early in the pandemic. There were 32 survey respondents; 14 represented academic programs, and 18 represented community-based programs. Respondents indicated that COVID-19 is leading programs to halt or prioritize screening and/or enrollment for certain clinical trials and cease research-only visits. Most reported conducting remote patient care where possible and remote visits and monitoring with sponsors and/or contract research organizations (CROs); respondents viewed this shift positively. Numerous challenges with conducting clinical trials were reported, including enrollment and protocol adherence difficulties with decreased patient visits, staffing constraints, and limited availability of ancillary services. Interactions with sponsors and CROs about modifying trial procedures were also challenging. The changes in clinical trial procedures identified by the survey could serve as strategies for other programs attempting to maintain their clinical trial portfolios during the COVID-19 pandemic. Additionally, many of the adaptations to trials made during the pandemic provide a long-term opportunity to improve and transform the clinical trial system. Specific improvements could be expanded use of more pragmatic or streamlined trial designs, fewer clinical trial–related patient visits, and minimized sponsor and CRO visits to trial programs. </jats:p>

The Impact of COVID-19 on Cancer Screening: Challenges and Opportunities

“…It is estimated that 606,520 Americans will die from cancer in 2020 [ 1 ], which is 4 times the number of recent projected deaths due to COVID-19 [ 2 ]. While cancer prevention and screening is integral to personal and population health, the cancer industry is experiencing seismic changes due to the COVID-19 outbreak [ 3 , 4 ]. Disruptions brought by COVID-19 have significantly interrupted almost all aspects of cancer control and prevention infrastructures, including canceled cancer screening services [ 3 ], deferred elective surgeries [ 5 ], dismantled therapeutic regimens [ 4 ], and furloughed health care practitioners [ 6 ].…”

COVID‐19 pandemic and impact on cancer clinical trials: An academic medical center perspective

“…In addition, the decision whether to continue cancer clinical trials became a safety concern regarding the treatment effect on cancer patients’ vulnerability for COVID‐19 contraction, potential viral exposure risk to clinical trial staff, and potential impact of an infected clinical trial cancer patient on study outcomes 8,9 …”

The New Normal in Clinical Trials: Decentralized Studies

“…These measures and others mitigate the risk of skipped doses, missing data, and early study termination and have been adopted in clinical trials across disease areas, from cancer to stroke. 1,4,5 Whereas helpful, these steps are merely temporizing. Current clinical trials have fundamental shortcomings.…”