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March 30, 2021

Poll suggests trial protocol should be changed for remote monitoring

Covid-19 has necessitated remote monitoring to continue clinical trials without risking public health.

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.

Future clinical trials protocol will be amended to include remote monitoring

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.

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