E-Consent-a guide to maintain recruitment in clinical trials during the COVID-19 pandemic.

ABSTRACT:

Background

The COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomized clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate, and patients' experience using e-Consent.

Methods

A substantial amendment of the protocol granted the creation of a remote e-Consent framework based on t

SUBMITTER: Almeida-Magana R 

PROVIDER: S-EPMC9096749 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature