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

Abstract

PURPOSE: The COVID-19 pandemic has led to profound changes in clinical research, including remote consent, telehealth, off-site procedures, shipment of therapy, and remote study monitoring. We assessed longitudinal perceptions of these adjustments among clinical research professionals. METHODS: We distributed an anonymous survey assessing experiences, perceptions, and recommendations regarding COVID-19–related clinical research adjustments to cancer clinical research office personnel in May 2020 and again in November 2020. Responses were compared using Fisher's exact and Mann-Whitney U tests. RESULTS: A total of 90 of 102 invited research personnel (88%) responded. Fifty-three (59%) reported participating in both initial and follow-up surveys. The proportion of respondents reporting personal experience with COVID-19–related adjustments increased over time, particularly for remote initial consent (29% v 4%), remote reconsent (24% v 9%), and remote study monitoring (36% v 22%). Perceived impact of COVID-19–related adjustments on data quality ( P = .02) and patient experience ( P = .002) improved significantly. However, perceived effect on patient safety ( P = .02) and respondent's experience ( P = .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P = .04), remote monitoring (69% v 45%; P = .05), and therapy shipment (67% v 35%; P = .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P = .13) and telehealth visits (66% v 45%; P = .08). CONCLUSION: More than 6 months into the global pandemic, perceptions of COVID-19–related clinical research changes remain favorable. Experienced individuals are more likely to recommend that these changes continue in the future.

Taking Tele Behind the Scenes: Remote Clinical Trial Monitoring Comes of Age During the COVID-19 Pandemic

“…As we and others have shown, there is strong support among clinical research professionals for extending some of these practices, in particular remote consent, telehealth visits, shipment of oral therapy, and remote study monitoring. [6][7][8] However, rendering these changes permanent features of clinical trial operations also requires buy-in from sponsors, sites, and CROs.…”

Telemedicine and Cancer Clinical Research

“…37,38 Professional organizations further promoted these changes. 39 Clinicians, patients, and study sponsors seemed to welcome telemedicine practices and support the continuation of these policies after the pandemic. 36,[39][40][41] These measures allowed large trials such as the international phase I/II CodeBreaK100 trial of sotorasib to be conducted during the pandemic with efficient enrollment throughout the world and shipment of the oral medication directly to patients.…”

Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach

“…It also can contribute to non-generalizable samples due to bias in enrollment of those who can surmount hurdles and who are easily accessible to researchers. A promising approach to overcoming these barriers is the integration of technology such as telehealth visits, digital consent, and application of remote patient monitoring devices into clinical trial design [3,[7][8][9]. In addition, for some studies, research participants collect their own samples at home and mail them to a lab for analysis [10,11].…”