Seamless collaboration on a complex co-sponsored oncology study in three APAC locations

A Europe-based biotech company that had recently gone public sought ICON’s support on a global oncology 
study. The study investigated a novel treatment of advanced solid tumours in the head and neck. This phase 3 
study was pivotal to demonstrate the efficacy, safety and potential future value of the treatment.

This was a complex study requiring three different investigator specialties: oncologist, radiologist, surgeon/ interventional radiologist. Protocol design was complex and the clinical trial participants were hard to find due to several stringent criteria and the age requirement of over 75 years. The global target was 500 randomised patients, 100 of whom were to be located across China, South Korea and Taiwan. The goal for site activation completion in APAC was between July 2022 and January 2023 with participant enrolment by the fourth quarter of 2024. 

Shortly after ICON was awarded the study the sponsor entered a partnership agreement with a pharmaceutical company in China. ICON proposed providing the CRO services in China, South Korea and Taiwan. However, the partner, which was funding the study in these locations, wanted to continue to use their preferred CRO. ICON and the third party CRO (3PCRO) collaborated to ensure that site activations and the studies ran smoothly.

During the start up phase ICON arranged a series of stakeholder meetings to ensure alignment between the sponsor, partner, ICON and 3PCRO. These highly collaborative meetings covered a range of issues, including: 

• operational model definition
• legal aspects 
• project oversight requirements 
• planning key operational areas, processes and tasks
• establishing SOPs
• roles and responsibilities
• communications plan
• project deliverables and timelines 

Prompt updates of the study management and financial plans, timelines management and system access processes ensured the rapid onboarding of the partner and 3PCRO study teams. 

Transparency, agility and communication were central to the successfully unite the various parties to work as one team. A cross-functional, inter-company RACI matrix clearly defined everyone’s roles and involvement throughout the study. The sponsor developed a quality oversight plan to support quality management activities with many of the targeted key quality indicators (KQIs) based on ICON’s KPIs.

ICON’s agility, flexibility and collaborative skills ensured positive working relationships between all of the organisations. This expedited the integration of the partner and 3PCRO study teams within the study’s global management. With ICON’s support the 3PCRO was enabled to set up their operations effectively and efficiently by January 2022. Half of the site activations were achieved by September 2022, and 91% completed on time by January 2023. The remaining 9% of sites were activated by March 2023. 

Despite the very challenging recruitment of difficult to find trial participants, a 60% enrolment target was achieved by the end of 2023. Close cooperation between the sponsor, ICON, the partner and the third party CRO was central to this success. Ongoing sharing of lessons learned and best practices by all parties meant that issues could be anticipated and resolved effectively. Continuous improvements and transparent communications ensured that key performance indicators and study milestones were met. ICON’s flexibility and willingness to work to our customers’ preferences contributed to the successful completion of the study.