Abstract
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 the REDCap environment, following the structure and content of the already approved paper consent form. Although e-Consent obviated the need for in-person meeting, there was nonetheless counselling sessions performed interactively online. This new pathway offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation.
Results
Before the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation.
Conclusion
Remote e-Consent-based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues.
Trial registration
NeuroSAFE PROOF trial NCT03317990. Registered on 23 October 2017. Regional Ethics Committee reference 17/LO/1978.
Funder
University College London Hospitals NHS Foundation Trust
The Jon Moulton Charity Trust
St. Peters Trust
Research for Patient Benefit Programme
Rosetrees Trust
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference28 articles.
1. World Health Organization. WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int/. Accessed 3 Dec 2021.
2. Wyatt D, Faulkner-Gurstein R, Cowan H, Wolfe CDA. Impacts of COVID-19 on clinical research in the UK: a multi-method qualitative case study. Plos One. 2021;16(8):e0256871.
3. Asaad M, Habibullah NK, Butler CE. The Impact of COVID-19 on Clinical Trials. Ann Surg. 2020;272(3):e222–e3.
4. NHS Health Research Authority. Making changes to a research study to manage the impact of COVID-19. https://www.hra.nhs.uk/covid-19-research/covid-19-guidance-sponsors-sites-and-researchers/ Accessed 3 Decer 2021.
5. FDA. Conduct of clinical trials of medical products during the COVID-19 public health emergency 2020. https://www.fda.gov/media/136238/download. Accessed 3 Dec 2021.
Cited by
13 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献