Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments.

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' professi

SUBMITTER: Gerber DE 

PROVIDER: S-EPMC8173586 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature