Covid-19 has necessitated remote monitoring to continue clinical trials without risking public health.
Verdict has conducted a poll to assess whether clinical research professionals are planning to amend their future trial protocols to include remote monitoring.
Analysis of the poll results shows that a majority 64% of the respondents are planning to amend their future trial protocols to include remote monitoring, while 36% don’t plan to make such amendments.
The analysis is based on 369 responses received from the readers of Clinical Trials Arena, a Verdict network site, between 27 July 2020 and 22 March 2021.
Remote monitoring in clinical trials management during COVID-19
The Covid-19 pandemic has led to uncertainty over clinical trial completion, participant retention in ongoing studies, and trial continuity. Lesser number of staff on-site and limited on-site monitoring of clinical trials built upon the travel restrictions and measures imposed for the safety of sponsors or contract research organisations (CRO) have compounded the issues of on-site clinical trial monitoring.
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The US Food and Drug Administration (FDA) and EU released guidance supporting remote monitoring for conducting clinical trials during Covid-19. The EU, however, did not include remote source data verification (SDV) in its guidance. The condition can result in more on-site monitoring after the pandemic condition normalises.
Remote monitoring and remote access to electronic health records (EHRs) were feasible before Covid-19 restrictions but were not implemented effectively. The Covid-19 restrictions highlighted the importance of remote monitoring for clinical trials, which can also be potentially harnessed post pandemic.