Optimizing Oncology Clinical Development Programs Via Risk-Based Quality Management (RBQM)
March 31, 2023White Paper
There are currently more than 700 oncology drugs in later stages of development (Phase II or higher), representing a 60% increase from just a decade ago. Indeed, the percentage of the global drug pipeline dedicated to oncology increased by over 60% in the past decade, from 26.8% in 2010 to over 35% in 2019.1 Cancer drugs continue to represent a larger part of the overall drug pipeline, driven by the tremendous expansion in our understanding of cancer cell biology. Technological innovations are able to exploit our evolving comprehension of cancer cell biology, and there is little doubt that this predominance will continue.
Because these innovative approaches are driving the oncology drug pipeline, it is critical that your CRO understands the need for leading technological tools and solutions in drug development programs. ARG has consistently made investments in technology since 2004, enabling us to address the most important feature that is required from an oncology-focused CRO in order to facilitate development of your new anti-cancer agent: development, adaptation and use of technology. In a data-driven world, ARG is a technology-driven oncology CRO.
ARG’s utilization of technology to facilitate the drug development process is apparent by looking at how Risk-Based Quality Management (RBQM) strategies are integrated into clinical trials according to ICH E6 (R2). RBQM employs various technologies to identify signals that indicate potential risks with trial conduct, patient safety or data integrity, for example. RBQM fulfills regulatory requirements while allowing for a more targeted approach to monitoring, in that 100% Source Data Verification (SDV) would be required at high-risk sites based on triggered events or certain predefined critical events in the study while targeted monitoring would be acceptable at other sites.
Both FDA and EMA accept that less SDV is appropriate through targeted monitoring in lower-risk studies and in lower-risk periods of initially higher-risk studies2.
RBQM allows sites to shift focus to critical data and processes, which improves patient safety while improving the quality of critical data. Thus, RBQM is a valuable concept in clinical research, providing higher quality data while potentially reducing the overall cost and time to approval of an investigational agent. Sponsors realize the benefit of more efficient allocation of resources at the site level and protection of patient safety, data integrity and Good Clinical Practice (GCP) compliance.
The implementation of RBQM in an oncology study begins with the development of a Risk Assessment and Categorization Tool (RACT) to identify key risk indicators (KRI). Once study-specific KRIs are determined, a custom-designed risk mitigation strategy is formulated based on the findings. To mitigate the risks, RBQM is put into practice using centralized monitoring and targeted monitoring. Centralized monitoring is remote aggregation of all the data from all systems of a given oncology trial for the purpose of analysis.
The output, clearly displayed on dashboard reports, provides metrics and KPIs. Targeted monitoring is 100% SDV of pre-determined critical data points versus all data points. Together, this custom approach allows all project team members the ability to check on the status of the trial on a frequent basis. As a result, the project team can focus on the data that needs the most attention at any given time by identifying trends that may need to be investigated further at a site, patient, or study level.
RBQM provides CRAs the ability to dynamically alter a visit schedule based on the data that is being collected at the site on a real-time basis. Additionally, the use of central monitoring could trigger requests that different data be evaluated at different visits based on the site’s performance data.
These are just two simple examples.
The result is higher quality data without additional costs compared to what 100% SDV would require. The number of on-site monitoring visits might be reduced considerably for well-performing sites. Resources could then be shifted to help under-performing sites. The bottom line is that using innovative strategies and tools allows for more efficient allocation of resources.
At ARG, we invite you to discuss with us how we can use our technology focus to enhance your oncology drug development process, including the utilization of risk-based quality management approaches.
References
- Informa R&D Annual Review 2019
- FDA Guidance for Industry: Oversight of Clinical Investigations–A Risk-Based Approach to Monitoring 2013
