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The Clinical Trials Industry’s Weekly News Update

Decentralization helped trial sector overcome COVID-19, but at a cost

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Decentralized clinical trial technologies helped European CROs restart trials halted by the pandemic. However, according to a new study, adopting this way of working impacted budgets and resources.

The research – which was published in February – is based on feedback from forty nine European Union (EU) based contract research organizations (CROs) that were asked about impact of the coronavirus pandemic.

And – according to the authors –the initial impact was significant.

“We saw an almost immediate decline in clinical trial activity associated with reduced subject/patient recruitment and a reluctance of study participants to undergo follow-up due to their fears of exposure to infection.”

The authors added that “No responders avoided trial disruption resulting from the pandemic measures, with 63% of the responders recording a marked or ‘serious’ impact on their ongoing trials and almost a third (30%) noting that the impact was ‘extremely serious’.”

The analysis suggested Phase III trials were more markedly affected than earlier phase trials.

The most frequently reported issue related to hospital recruitment because investigators were no longer able to conduct trials and/or patients unwilling to make hospital visits.

In addition, 35% of respondents said the pandemic caused operational issues – such as delays in dispensing investigational medicines, the delayed initiation of site visits and issues around laboratory sample processing.

Decentralization

As time passed, sponsors and CROs sought to bypass the disruption by adopting decentralized trial models and associated technologies. And, while this was effective in terms of allowing research to restart, the switch to remote studies will have a lasting impact the authors said.

“The introduction of remote monitoring by CROs provided the opportunity for essential activities associated with clinical trials to resume/continue.

“However, implementing these solutions required research organizations to implement changes to trial documentation and procedures. This placed marked burdens on budgets and clinical resources.”

Image: Stock Photo Secrets

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