Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments.
J Natl Compr Canc Netw
; 19(5): 505-512, 2021 05.
Article
in English
| MEDLINE | ID: covidwho-837629
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Telemedicine
/
Practice Guidelines as Topic
/
Delivery of Health Care
/
Interdisciplinary Communication
/
Biomedical Research
/
SARS-CoV-2
/
COVID-19
Type of study:
Observational study
/
Prognostic study
/
Qualitative research
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
J Natl Compr Canc Netw
Journal subject:
Neoplasms
Year:
2021
Document Type:
Article
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