Risk-based approaches to monitoring (RBM) have become widely accepted in the clinical trials industry. Due to limited financial and operational resources, smaller organizations face multiple challenges when adapting to rapid industry changes. A variety of factors contribute to the slower adoption of RBM in smaller organizations.
This case study seeks to share the experience of a sponsor organization that decided to utilize RBM in a limited, but effective manner during a global study, spanning 40 sites across seven countries. The sponsor team believed in risk-based monitoring and the potential benefits of that approach, but was not in a position to fully implement RBM for a variety of reasons, including a reliance on the processes and procedures established by the CRO.
Acuity Analytics — an integrated data analytics and RBM enablement platform — was utilized for developing data visualization and custom analytics for monitoring the KPIs, KRIs and specific critical data. The custom dashboards and analytics were designed in alignment with the sponsor’s specific needs. Data sources included an electronic data capture (EDC) system and the CRO’s clinical trial management system (CTMS). These were seamlessly integrated with Acuity Analytics.
The outcome of this pilot demonstrated a viable approach for small and midsize organizations to implement risk-based approaches to monitoring. The small steps taken in a pilot study, along with an expert’s help, represent a plausible way to get hands-on understanding of the nuances of execution as well as foresee challenges when RBM requires implementation in a scalable manner on more studies.
Utilization of technology will be key and could level the playing field between large and small organizations. Research organizations can overcome apprehensions about investing in comprehensive enablement technology by procuring easy-to-use, smart and customizable innovative technologies on a study-to-study basis. This can be a quick-and-easy starting point before pursuing a strategic roadmap.
For the full case study, read a new article in Applied Clinical Trials from Abby Abraham, (photo) vice president of Data Analytics and Risk-Based Monitoring at OmniComm Systems, Inc., and Ranjeet Gutte, general manager, Global Clinical Development for Wockhardt Ltd.