Experience, Perceptions, and Recommendations Concerning COVID-19–Related Clinical Research Adjustments

Abstract

Background: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. Methods: We developed and distributed an anonymous survey assessing COVID-19–related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. Results: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19–related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). Conclusions: Clinical research professionals perceive that COVID-19–related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19–related changes and more generally—are more likely to recommend that these adjustments continue in the future.

Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine

“…The COVID-19 pandemic has influenced practical changes in the way in which cancer treatments can be administered and how patients can be monitored, including remote assessments and telehealth 37–39 . A shift to identify and apply transferable approaches learned from the COVID-19 vaccine strategy may enhance practical steps to further cancer treatment development.…”

“…The COVID-19 pandemic has influenced practical changes in the way in which cancer treatments can be administered and how patients can be monitored, including remote assessments and telehealth. [37][38][39] A shift to identify and apply transferable approaches learned from the COVID-19 vaccine strategy may enhance practical steps to further cancer treatment development. Lessons extrapolated from the COVID-19 pandemic may help to adapt oncology studies to proceed more rapidly with greater representation of patients from diverse demographic backgrounds and disease states.…”

Longitudinal Experience With and Impressions of COVID-19–Related Clinical Research Changes

“…[8][9][10] To assess the perceived impact of COVID-19-related clinical trial adjustments, approximately 1 month into pandemic clinical trial operations, we distributed a survey to clinical research professionals at a National Cancer Institute (NCI)-designated comprehensive cancer center. 11 We targeted these individuals because of their familiarity with protocol requirements and contact with patients, investigators, sponsors, and regulatory agencies. 12,13 Because the initial survey was conducted at the outset of the COVID-19 pandemic, we reassessed reactions to COVID-19related clinical trial adjustments 6 months later.…”

Cancer prevention, risk reduction, and control: opportunities for the next decade of health care delivery research

“…When EBPs are incorporated into delivery, the average time from discovery to translation takes approximately 17 years [ 3 ]. The COVID-19 pandemic illustrated that, when faced with a threat, the cancer care delivery system can swiftly adapt to re-align and focus diverse stakeholders’ interests to achieve a common goal [ 4 ]. A key challenge in the next decade is to align diverse stakeholders, including patients, health care professionals, payors, health care delivery organizations, and non-profit cancer-specific organizations’ interests to accelerate behavioral health care innovation into cancer care delivery and cancer control efforts more broadly [ 5 ].…”