Researcher experience and comfort with telemedicine and remote patient monitoring in cancer treatment trials.
Authors: Lichtenstein Morgan RL , Levit Laura , Schenkel Caroline , Kirkwood Margaret Kelsey , Kelley Michael J. , Mailman Josh , Magnuson Allison , Mirda Daniel P. , Natesan Divya , Fashoyin-Aje Lola A. , Hershman Dawn L. 
Published: September 2022

385 Background: Since the onset of COVID-19, oncology practices across the U.S. have integrated telemedicine (TM) and remote patient monitoring (RPM) into routine care and clinical trials. However, the extent of provider experience and comfort with TM/RPM in treatment trials is unknown. In this study, we surveyed oncology researchers to assess experience and comfort with TM/RPM. Methods: Between April 10 and June 1, 2022, we distributed email surveys to U.S.-based members of the American Society of Clinical Oncology (ASCO) whose member records indicated an interest or specialization in clinical research. We collected respondent demographic data, clinical trial experience, and workplace characteristics, as well as frequency and impression of TM/RPM use across trial components in phase 1, phase 2/3, and post-treatment trials. TM/RPM was defined as clinical trial-related health care and monitoring for patients geographically separated from the site administering the clinical trial. Results: There were 141 respondents. 53% identified as female. 39% were under 45 years old, and 25% were over 60. 70% identified as White. 90% were site or study PIs. 98% practiced in a non-rural site. Most respondents had enrolled patients on industry-sponsored trials (97%), NCI-sponsored trials (84%), and investigator-initiated trials (83%), across Phase 1 (92%), Phase 2/3 (100%), and post-approval trials (75%). About 41% of respondents had >20 years of trial experience. Regarding remote care in treatment trials, 75% reported using TM, RPM, or both. Among these individuals, 62% had never provided remote care to trial patients before the pandemic. For Phase 2/3 trials, while > 75% of respondents expressed comfort (C) using TM/RPM for some trial components, the corresponding experience (E) in these areas was lower. Specifically for Phase 2/3 trials, comfort levels exceeded experience for pre-screening (C = 91% vs. E = 47%), education and counseling (C = 95% vs. E = 52%), informed consent (C = 79% vs. E = 30%), routine lab testing (C = 81% vs. E = 37%), symptom monitoring for adverse events (C = 88% vs. E = 55%), PROs in real time (C = 87% vs. E = 20%), PROs as a study endpoint (C = 89% vs. E = 27%), and long-term outcome monitoring (C = 90% vs. E = 47%). Notably, 60% of respondents ranked patient access as the top advantage of providing TM/RPM in treatment trials. Top disadvantages included limited ability to monitor patients (34%) and disparities in patient technology access (23%). More than a quarter of respondents identified the top barrier to use of TM/TPM as trial regulations (29%) or cross-state licensure challenges (27%). Conclusions: COVID-19 spurred the rise of TM/RPM in cancer treatment trials. Among oncology researchers, higher levels of comfort compared to real-world experience with TM/RPM reveal opportunities for expanding TM/RPM policies and guidelines in oncology research.