TY - JOUR
T1 - Longitudinal Experience With and Impressions of COVID-19–Related Clinical Research Changes
AU - Gerber, David E.
AU - Clark, Valerie L.
AU - Sheffield, Thomas Y.
AU - Beg, Muhammad S
AU - Xie, Yang
AU - Blair Holbein, M. E.
AU - Skinner, Celette Sugg
AU - Craddock Lee, Simon J.
AU - Williams, Erin L.
N1 - Funding Information:
Supported in part by a National Cancer Institute Midcareer Investigator Award in Patient-Oriented Research (Grant No. K24CA201543-01), the Biostatistics Shared Resource of the Harold C. Simmons Comprehensive Cancer Center (Grant No. 5P30 CA142543), and UT Southwestern Academic Information Systems (CTSA NIH Grant No. UL1TR001105).
Publisher Copyright:
© 2021 by American Society of Clinical Oncology.
PY - 2022/1/1
Y1 - 2022/1/1
N2 - 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 5 .02) and patient experience (P 5 .002) improved significantly. However, perceived effect on patient safety (P 5 .02) and respondent’s experience (P 5 .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P 5 .04), remote monitoring (69% v 45%; P 5 .05), and therapy shipment (67% v 35%; P 5 .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P 5 .13) and telehealth visits (66% v 45%; P 5 .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.
AB - 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 5 .02) and patient experience (P 5 .002) improved significantly. However, perceived effect on patient safety (P 5 .02) and respondent’s experience (P 5 .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P 5 .04), remote monitoring (69% v 45%; P 5 .05), and therapy shipment (67% v 35%; P 5 .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P 5 .13) and telehealth visits (66% v 45%; P 5 .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.
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U2 - 10.1200/OP.21.00169
DO - 10.1200/OP.21.00169
M3 - Article
C2 - 34324403
AN - SCOPUS:85115271430
VL - 18
SP - E98-E107
JO - JCO Oncology Practice
JF - JCO Oncology Practice
SN - 2688-1527
IS - 2
ER -