Understanding Risk-Based Quality Management (RBQM)

Ensuring patient safety is a critical objective across all clinical studies. To keep participants safe while simultaneously keeping clinical trials on track, proactive monitoring and early detection of potential risk play key roles in the drug development process. Initial guidance from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for adopting a risk-based approach to clinical trial monitoring was released almost 10 years ago. The FDA and EMA continue to press the industry to meet the guidance objectives. This guidance, in addition to continuous updates to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards around total quality management objectives, have caused risk-based monitoring (RBM) to become a more common practice across all clinical trials.

In recent years, the adoption of decentralized trial (DCT) models has created both opportunities and challenges in clinical development. While DCT models make clinical studies more accessible and relieves patient burden, the volume and variety of study data collected adds greater complexity to trial management and monitoring processes.

One strategy to address the increasing complexity of trial monitoring is to evolve from RBM to Risk-based Quality Management (RBQM) — which is an end-to-end process that begins with protocol design and focuses on factors critical to quality throughout the trial lifecycle. Our latest white paper highlights why the industry is moving towards RBQM and how sponsors can build a scalable approach that protects trial participants, helps manage risks, upholds study integrity, and increases operational efficiencies.

Understanding Risk-Based Quality Management

How Does RBQM Differ from RBM?

Risk-based monitoring (RBM) and Risk-based quality management (RBQM) share a similar focus on identifying and mitigating potential risks. Where RBM and RBQM differ is in how widely they are applied in a trial.

RBM is a piece of an overarching RBQM strategy and while RBM uses advancements in technology and analytics to track and predict risks, RBQM is a more expansive process. Focusing on factors critical to trial quality, RBQM begins at the time of protocol design — so that mitigation can be built into the protocol and other trial documents — and identifies risk on an ongoing basis for the duration of the trial. In today’s evolving clinical trial landscape, a clinical trial often includes millions of data points, making RBQM more essential than ever before. When sponsors leverage this end-to-end methodology, trial participant risk is reduced, and costly downstream issues are avoided.

Current State of RBQM Adoption in the Market

Over the last two years, the life sciences industry has seen a dramatic acceleration in digitization and technology adoption, especially in clinical development. The industry has embraced numerous technical capabilities such as decentralized trial platforms and RBQM software solutions that had been “emerging” for many years and are now becoming mainstream.  

The Gartner 2022 Hype Cycle for Life Science Clinical Development — which explores areas of innovation that will enable life sciences organizations to respond to industry challenges — recently highlighted this trend. In this report, risk-based and central monitoring approaches were classified as “on the Slope of Enlightenment.” This classification indicates that over the next two to five years, the implementation and expansion of RBQM practices by sponsors will gain increasing momentum as digital transformation continues, driving the need for more advanced RBQM technology and strategies to support innovation and the adoption of these approaches.

Drivers for RBQM Adoption Across Clinical Trials

While RBM adoption within the drug development industry has been on the rise for years, regulatory and external factors are driving life sciences organizations to take it a step further and evolve from RBM to RBQM in order to meet the demands of more adaptive and digital clinical trials.

Risk-based monitoring started to gain traction in 2013 when the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) released guidance for adopting risk-based approaches for more efficient trial monitoring. In 2016, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released ICH E6 (R2), requiring sponsors to develop risk-based methods to assess and manage trial risk. Following that, the FDA placed ICH E6 (R2) as a revision to Good Clinical Practice (GCP) in the federal registry. The third revision to ICH E6 is expected in 2022 and will focus on risk-based approaches and the concept of quality by design while acknowledging the diversity of trial design, data sources, and different contexts in which clinical trials can be conducted. Additionally, RBM guidance and approach documents released by pre-competitive alliances such as TransCelerate BioPharma have helped to further drive the adoption of risk-based approaches. 

The Covid-19 pandemic has been an undeniable force in bringing sweeping changes to the way clinical research is conducted. Most significantly, the pandemic has been a catalyst for moving away from inefficient practices and pushing new clinical trial execution models to become standard practice. With remote and virtual monitoring approaches becoming mainstream, many organizations were forced to prioritize risk-based approaches, further accelerating the initiatives set in motion by ICH E6 (R2). The pandemic has proved that the drug development industry can no longer rely on inefficient trial execution models and must instead pivot to approaches that prioritize proactive risk assessment and mitigation.

Furthermore, these drivers for adoption are impacting both insourced and outsourced trial models. Emerging and mid-size sponsors working in outsourced models are adopting RBQM at an increasing rate. Using RBQM technology and methodology in an outsourced model enables sponsors to take a data-driven approach to overall risk assessment and analysis, creating additional value to supplement a CRO’s oversight strategy. Read this whitepaper to explore how you can implement a holistic RBQM strategy to ensure quality throughout the clinical trial lifecycle.

Access the Whitepaper