After the award of a moderate-to-severe plaque psoriasis study targeting the enrollment of 30 adult participants the sponsor decided to change key elements of the study design. Using ICON’s early patient solutions approach the site and country distribution was adjusted to reflect the sponsor’s needs. Despite a global pandemic, recruitment goals were achieved according to revised and agreed timelines with an above-average enrollment rate for this patient population, requiring six months from first patient screened to last patient’s first dose.

The sponsor made major changes to the study design which posed significant challenges and required a new feasibility study post-award. Limited leverage on specialised vendors caused additional challenges to procuring custom devices and laboratory supplies. Individual sites also encountered recruitment difficulties due to the COVID-19 pandemic.

ICON was able to quickly adapt to the client’s needs, especially in the highly versatile early phase/early patient setting. Close communication with principal investigators/sites, vendors, individual departments, and the sponsor was vitally important.

An experienced early phase team revised the feasibility and site identification process to accommodate the changes to the study design. ICON vendor management worked closely with the operational team to find the most suitable vendors and suppliers in response to the sponsor’s need to limit lead times. ICON and the sponsor held joint vendor calls to facilitate communication, regardless of the contracting party.

The assessment of opportunities for collaborative site support, close monitoring of recruitment progress, and regular reporting to the sponsor were all crucial to the success of this study. The swift addition of new sites, including submission and approval by authorities due to short turnaround times required ICON to deploy unified functional groups, including medical writing, vendor management, and clinical site contracting.

Leveraging ICON’s range of specialised therapeutic, operational, and drug development expertise the early patient solutions team selected and managed the ideal sites to achieve recruitment targets, despite changes in study design, the activation of fewer sites than initially planned, and the general challenges of a global pandemic. The study experienced an overall enrollment rate of 1.3 patients/site/month (p/s/m), compared to an analysis of the competitive landscape’s yield of a projected median enrollment rate
of 0.35 p/s/m.