Upcoming ICH GCP guide will increase use of risk-based monitoring, says ACRO

Mid-sized CROs are embracing risk-based monitoring strategies in trials, according to US industry group ACRO, which says upcoming good clinical practice (GCP) guidelines will further accelerate adoption.

ACRO group made the prediction based on a member survey conducted last year, revealing that in 2023, 88% of trials had at least one risked-based monitoring (RBM) or risked-based quality management (RBQM) component included, up from 53% in 2019.

The increase reflects a change in the CRO sector’s approach to information management, with more contractors having the ability to centralize data from trial sites, according to ACRO.

“The industry is at a tipping point. More than half of new studies utilize risk assessments, KRIs, centralized monitoring, and remote monitoring,” the authors wrote, pointing out that risk-based monitoring is most popular with mid-tier CROs.

“Mid-size sponsors had higher adoption rates compared to small sponsors. Generally, in our experience, smaller sponsors are more reluctant to invest in centralized monitoring when designing a study.”

Adoption of RBM has also been slower among larger CROs running larger studies. For such programs, traditional source data verification (SDV) and source data review (SDR) monitoring practices continue to dominate according to ACRO.

“In large, mega-sized studies, 100% SDR/SDV is being used 32% to 53% of the time. This is costing the industry a lot of time, cost, and human resources for little return,” the authors said.

ICH E6 (R3) and efficiency

In time, RBM use in larger studies is likely to increase, according to ACRO, which pointed to technology advances and industry’s desire for efficiency as the key dynamics.

“Centralized monitoring gives sponsors and CROs a better view of the data compared to 100% SDR/SDV. This makes it possible to analyze the data in real-time, increasing trial efficiency and participant safety.

“Sponsors and CROs cannot just reduce SDR or SDV alone, this must be done after centralized monitoring has been initiated. This will save costs and increase data quality in the long run,” the authors wrote.

ACRO also said completion of the International Council for Harmonisation’s ICH E6 (R3) guideline on GCP – which observers say is due this year – will increase the use of RBM.

“The finalization of ICH E6(R3) will further help the industry take risk-based and quality forward approaches to clinical trial management.”

Unsplash/Arisa Chattasa