How Risk-Aware Are You? Establishing A Foundation For A Holistic RBQM Strategy

Ensuring patient safety is a critical objective across all clinical studies. To keep participants safe, while 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 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 trials 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. This paper will highlight why the industry is moving towards RBQM and how sponsors can build a scalable approach that protects trial participants, upholds study integrity, and increases operational efficiencies.