The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic.

ABSTRACT:

Background

The World Health Organization declared the outbreak of SARS-CoV-2 a pandemic on February 11, 2020. This organism causes COVID-19 disease and the rapid rise in cases and geographic spread strained healthcare systems. Clinical research trials were hindered by infection control measures discouraging physical contact and diversion of resources to meet emergent requirements. The need for effective treatment and prevention of COVID-19 prompted an untested investigational response. Trial groups adapted approaches using remote enrolment and consenting, newly developed diagnostic tests, delivery of study medications and devices to participants' homes, and remote monitoring to ensure investigator/enrollee safety while preserving ethical integrity, confidentiality, and data accurac

SUBMITTER: Liu HH 

PROVIDER: S-EPMC8422835 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature