Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments
Open accessAbstract
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.
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The same study found clinicians and investigators were less positive about the changes, mainly those related to administering treatment and off-site procedures.
“Interestingly, the same study found clinicians and investigators were less positive about the changes, mainly those related to administering treatment and off-site procedures.”
From Legacy lessons from the COVID-19 era to improve trial participation and retention: Views from trial participants, PPIE contributors and trial staff across the NIHR portfolio (2024) · cites this paper as [19]
The Discussion says the perceived reaction of clinicians/investigators was less enthusiastic, particularly for off-site procedures and treatment administration. The claim omits that these were respondents’ perceptions, rather than clinicians’ and investigators’ directly reported views. (LLM, conf=0.85)
Experimental — accuracy not yet measuredMost respondents in that survey felt changes should continue post-pandemic including telehealth visits, remote consent and conducting diagnostic procedures or treatments off-site.
“Most respondents felt changes should continue post-pandemic including telehealth visits, remote consent and conducting diagnostic procedures or treatments off-site.”
From Legacy lessons from the COVID-19 era to improve trial participation and retention: Views from trial participants, PPIE contributors and trial staff across the NIHR portfolio (2024) · cites this paper as [19]
The Results report broad support for continuing positive adjustments after the pandemic. But only a minority of all respondents recommended continuing the named changes: telehealth (44%), remote consent (37%), off-site diagnostic procedures (26%), and off-site treatment (14%). The claim conflates general support with majority support for each specific change. (LLM, conf=0.90)
Experimental — accuracy not yet measuredA survey of clinical research office personnel found a perceived improvement in communication with participants, investigators and sponsors, patient safety, treatment efficacy, and the experience of both participants and staff related to Covid-19 adjustments to trials.
“A survey of clinical research office personnel assessing perceptions, experiences and recommendations related to Covid-19 adjustments to trials found a perceived improvement in communication with participants, investigators and sponsors, patient safety, treatment efficacy, and the experience of both participants and staff [19].”
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“…office personnel assessing perceptions, experiences and recommendations related to Covid-19 adjustments to trials found a perceived improvement in communication with participants, investigators and sponsors, patient safety, treatment efficacy, and the experience of both participants and staff [19].”
- Authors
- Gerber, D. E., Sheffield, T. Y., Beg, M. S., Williams, E. L., Clark, V. L., Xie, Y., Holbein, M. E. B., Skinner, C. S., & Lee, S. J. C.
- Affiliations
- Harold C. Simmons Comprehensive Cancer Center (US)
- The University of Texas Southwestern Medical Center (US)
- ORCID
- Venue
- Journal of the National Comprehensive Cancer Network
- Publisher
- Harborside Press, LLC
- Published
- 2021-05
- Volume
- 19
- Issue
- 5
- Pages
- 505-512
- ISSN
- 1540-1405 (ISSN-L)
- 1540-1413
- PMC
- PMC8173586
- OpenAlex
- W3092360866
- Cited by
- 23
- References
- 24
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 3 · 2023: 3 · 2022: 9 · 2021: 4
- FWCI
- 1.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of the National Comprehensive Cancer Network (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- University of Texas Southwestern Medical Center (UL1TR001105)
- Georgia Clinical and Translational Science Alliance (UL1TR001105)
- National Institutes of Health (UL1TR001105)
- National Cancer Institute ((CA142543), T32CA124334, K24CA201543, UG1CA233302, P30CA142543)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Oncology › COVID-19 and healthcare impacts
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Keywords
- COVID-19 pandemic, telemedicine, remote monitoring, patient safety, clinical research professionals, cancer clinical trials
- MeSH terms
- COVID-19, SARS-CoV-2, Delivery of Health Care, Humans, Surveys and Questionnaires, Telemedicine, Practice Guidelines as Topic, Interdisciplinary Communication, Biomedical Research
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