A large multinational pharmaceutical company received FDA breakthrough therapy designation for an oral kinase inhibitor for an anti-inflammatory therapy for atopic dermatitis (AD) and wanted to expedite the filing of the initial new drug application (NDA), which necessitated the collection of sufficient data to determine the safety and efficacy required for regulatory approval and commercialisation.

The client tasked ICON plc with managing six phase 3 clinical trials, with overlapping timelines, to further evaluate this drug in patients with AD. The large scope demanded that trials were set up, conducted, and reported on time and before other competition. The pivotal study required a tight timeline with accelerated enrollment to achieve regulatory submission in a highly competitive landscape.

After almost three years of managing the clinical trials, the COVID-19 pandemic spread globally, requiring our experts to shift strategies quickly to ensure the studies remained on track and ready for regulatory submission.

At the outset of the program, ICON quickly enlisted support from feasibility, study start-up, project management and clinical teams to collaborate with the client for successful execution of the program. This program received enhanced support from the ICON executive leadership team through strategic discussions during weekly meetings where progress was reported, and risks and mitigations were brainstormed and reviewed. Throughout the clinical program, ICON constantly reviewed and balanced team resources to allow for effective start-up and monitoring, tackled overlapping timelines through implementation of a robust patient engagement and retention plan, and ensured submission-ready data through ongoing data cleaning, reconciliation, and review, in order to guarantee that the timelines for applications were met.

To ensure the successful delivery of the program the ICON team implemented several measures, including agile resourcing and monitoring strategies. Specifically:

• ICON assigned a program manager to ensure consistency in delivery across studies, to share lessons learned, monitor overall study metrics and implement program-wide corrective actions and training, when needed. The program manager was also responsible for overseeing resource management, including weekly calls to review resource needs, and prompt management of any resourcing gaps.
• As new projects were initiated, ICON strategically transitioned staff from one study to another
• Clinical research associates (CRAs) were regionally assigned and cross-trained as needed to allow them to easily support other studies in the program
• A flexible monitoring strategy focused on risk-based monitoring, supported both onsite and virtual monitoring
• Guidelines were developed for CRAs, during the global pandemic, including providing personal protective equipment (PPE) for CRAs when traveling and conducting onsite activities

ICON’s experts provided flexible and strategic planning and execution in managing six clinical trials under a larger program. Despite COVID-19 disruptions, during the three years of trial oversight, the ICON team became adept at offering creative
monitoring solutions and quickly adjusting resources to maximize efficiencies and accelerate processes from study start-up to database lock, and close-out.

ICON delivered:

• Appropriate resourcing strategy to manage a large scope of work with overlapping timelines
• On-time delivery and excellence in operational execution through a project team with proven track records
• Quality oversight of data used for endpoints

The team consistently met, or exceeded, milestones across the program, including multiple data cuts to support regulatory submissions, even during the COVID-19 pandemic, allowing the client to make the NDA submission on time. Further, the client was able to submit the Marketing Authorization Application earlier than the initial timeline.