Optimising resources on a portfolio of large scale oncology studies

ICON provided full service support for a series of five in vitro diagnostic (IVD) studies. The global studies focused on a range of sample collection techniques and patient enrolment strategies for rapid diagnosis of colorectal cancer. More than 29,000 patients were enrolled across 250+ sites worldwide. While similar in scope and tasks, each study had unique characteristics. ICON managed most aspects of the studies on the sponsor’s behalf including project management, clinical monitoring, site management, data management and trial master file.

The scale and scope of the portfolio of studies presented challenges coordinating activities, training teams, and utilizing team members across multiple studies to optimise effectiveness and efficiency. Accurate financial forecasting of all five studies was essential to implement resource-sharing efficiencies.

ICON developed a program structure to optimise resources, conduct uniform training and share lessons across all five studies. Multiple project managers, clinical trial managers, data managers, and clinical research associates were cross trained on multiple protocols to:

1. Promote effective resource management across multiple studies
2. Ensure team members were trained to multiple site requirements to mitigate the risk of team transitions or turnover

This strategy guaranteed adequate coverage by experienced clinical trial staff across all studies and sites throughout the study timeline. 

To ensure that financial forecasting was accurate, a portfolio contract with an independent ICON study number was contracted with the client, allowing shared resources to charge time while working across the pool of studies. For example, project managers and clinical trial managers performing activities on multiple studies at varying critical time points. A program manager oversaw the sponsor’s partnership manual training, resource sharing, KPIs and financial forecasting of the portfolio. Alongside standard study level team meetings, ICON held governance meetings to ensure regular program level feedback. 

The program manager’s oversight ensured that all studies met their individual goals and maintained effective resource management. All studies concluded within the agreed timeframes to meet study goals. Financial forecasting achieved the sponsor’s forecasting goal, successfully predicting costs to an accuracy of plus/minus 10%. Individual studies reduced overburn due to portfolio contract for manager billing. Lessons learned were shared across all studies as they arose, and corrective actions implemented to mitigate risks related to monitoring and enrollment. The sponsor’s IVD products received FDA approval on schedule.