Risk-based monitoring gaining popularity in trials says ACRO

Use of risk-based management is increasing in clinical trials according to US industry group ACRO, which says regulations, tech and decentralized models are driving the change.

The industry group analyzed trial management in a newly published report, writing that at least one RBQM component was implemented in 88% of trials in the 2021 survey, compared with 77% in 2020 and 53% in 2019.

According to ACRO the most frequently implemented risk-based components were initial and ongoing risk assessments, which were used in 80 and 78% of trials, respectively.

They also revealed that greatest use of risk-based management occurred in early phase trials, writing that small trials - those involving fewer than 300 participants - accounted for 60% of those implementing RBQM.

The results reflect industry desire for better studies according to the authors, who wrote “clinical trial quality depends on ensuring participant safety and data integrity, which require careful management throughout the trial lifecycle, from protocol development to final data analysis.”

“Recent developments—including new regulatory requirements, emerging technologies, and trial decentralization—have increased adoption of risk-based monitoring (RBM) and its parent framework, risk-based quality management (RBQM) in clinical trials.”

Decentralized studies

ACRO has been tracking industry use of risk-based management since 2019. For the latest study, the organization analyzed data from 4889 clinical trials that were ongoing in 2021.

And, according to the authors, use of the approach is likely to go on increasingly, particularly as a result of decentralized study methods adopted since the beginning of the coronavirus pandemic.

They wrote “with the continued impact of the pandemic on how clinical trials are designed and executed and the increasing number of partially or fully decentralized clinical trials (DCTs), ACRO’s RBQM Working Group expects these adoption rates to continue to increase over time.”

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