Risk-based Quality Management Growing Rapidly in Clinical Trials: ACRO RBQM Working Group

Clinical trials are constantly evolving in response to technological advances, new data analysis methods, and diverse trial designs, such as decentralized clinical trials (DCTs). One of the significant developments in clinical trial management in recent years is implementing a risk-based quality management (RBQM) framework. The adoption of these approaches is increasing due to their efficiency, regulatory support, and enhancement of trial quality. Since 2020, RBQM uptake has dramatically accelerated—most likely due to the expansion of off-site trial activities such as centralized and remote monitoring during the COVID-19 pandemic. As adoption increases, the industry has looked to quantify these changes.

Medidata leads the ACRO RBQM Working Group, which has made significant strides to examine the end-to-end RBQM framework in detail and describe its unique benefits and challenges. The goal is to create better tools for the industry to support adoption and limit uncertainty and concerns around RBQM implementation. 

For the past three years, the group has conducted an annual landscape survey with member company CROs to determine how remote monitoring and risk-based quality management processes are being implemented across the industry. The group looked at adoption rates of remote monitoring, QTLs, centralized monitoring, and several other components. Data was collected on 5,000+ ongoing clinical trials for each of the past three years, and the latest findings are compiled in their recent publication. 

The paper summarizes three key takeaways:

1. Trials implementing RBQM capabilities increased from 53% in 2019 to 88% in 2021, showing major progress in RBQM adoption. The 2021 data also shows that 80% of trials implemented at least the initial risk assessment, and 78% implemented the ongoing risk assessment. This demonstrates the industry placing Quality by Design (QbD) practices in place.
2. The percentage of new studies in 2021 that included centralized monitoring was more than twice that for all 2020 trials. These findings highlight the growing importance of the central monitoring component as a key part of clinical trial execution.
3. On-site monitoring whose primary purpose is source data verification (SDV) is resource intensive. Despite strong evidence demonstrating that it’s less efficient and effective—and encouragement from regulators to employ strategic monitoring with reduced SDV—100% SDV remains ingrained in the clinical trial industry as the primary activity during on-site monitoring visits. The data indicates that only 27% of trials started in 2021 implemented centralized monitoring with reduced/targeted SDV and/or reduced SDR. This suggests an opportunity for continued industry growth towards reduced SDV/SDR through risk assessments to target data and processes critical to trial quality for on-site monitoring, which will increase trial efficiency.

By sharing this landscape data, the CROs and technology providers of ACRO hope to continue collaborating with all stakeholders—from ACRO members to sponsors and regulators—to make progress advancing the industry and how clinical trials are conducted most effectively and efficiently. 

Medidata has been delivering leading clinical technologies in the RBQM space for over 10 years, with a rich data culture and expertise supporting numerous landmark peer-reviewed industry publications on RBQM. 

Learn more about Medidata RBQM solutions.