RBQM in Its Prime: Companies Realize Lasting Benefits When Adopting Risk-based Approaches

The landscape of clinical trials has changed significantly in the last 24 months. Companies are now transitioning to take full advantage of the innovations born out of necessity during the pandemic. It’s clear that a risk-based approach to trial execution is paramount to ensuring success in the new clinical trial environment.

A recent Association of Clinical Research Organizations (ACRO) paper was published in Therapeutic Innovation & Regulatory Science and co-authored by Medidata thought leaders. This paper highlights that in 2020, 77% of the surveyed studies implemented at least one risk-based monitoring component—an increase from 47% for studies at the end of 2019. In addition, a 20% increase in risk assessments from 2019 to 2020 which was driven by 93% of 2020 new study starts included both initial and ongoing risk assessments. These data support the agility organizations have demonstrated to ensure participant safety and clinical data quality within the new normal of clinical trial development operations.

The ACRO paper further supports how organizations that implemented robust processes using RBQM (risk-based quality management) practices, including centralized monitoring, flexible on-site interactions, and remote data collection and document review, were agile in adjusting to the new and complex clinical trial environment. This rapid realization of benefits is the strongest argument in favor of fully implementing RBQM industry-wide. To fully realize these benefits, companies must connect technology and processes to enable efficient and scalable trials solutions driven by 3 core components:

1) Modular and unified RBQM capabilities

2) Data-centric solutions

3) Advanced clinical trials analytics and workflows

Modular and unified RBQM capabilities cover a broad set of processes, including risk management, critical data verification/review, centralized monitoring/oversight, issue management, and site monitoring. The optimized approach is achieved by implementing a collection of fit-for-purpose functional modules that are unified by a common technology and data platform. 

Data-centric RBQM solutions are essential to empowering an effective approach to quality by design (QbD) while also leveraging future innovations in predictive analytics. In a data-centric environment, there is one source of truth in which data is entered once and used elsewhere to add greater value to the overall study or portfolio. 

Advanced clinical trials analytics and workflows enable teams to be efficient and effective, and gives them access to:

• Insightful context to quickly understand how their studies and sites are performing.
• Collaborative environments in which disparate global teams communicate and triage issues and actions as if they are working in the same virtual page.
• Tools to detect and remediate issues early before they have a material impact on outcomes. 

The ACRO publication, in combination with ICH E6 (R3) draft principals, as well as MHRA guidance’s Risk-Adapted Approach to clinical trials and Risk Assessments and Oversight and monitoring of investigational medical product trials, highlight that clinical trials must be adapted to fit individual participant circumstances and the particular trial design. Risk-based approaches to clinical trial oversight are now at sufficient maturity where substantial benefits to time, cost, and outcomes can be realized.

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