ICON was contracted to conduct an early-phase clinical trial in Huntington’s disease across 12 countries and 53 sites. The study goal of randomising over 400 patients was in and of itself daunting, as this rare neurodegenerative disorder affects about 3 out of every 100,000 people of European ancestry. However, there were other challenges: the protocol specified 27 clinical and/or patient-reported outcomes in local languages, involved unblinded raters, and required support from 10 third-party vendors, posing complications for quality control and coordination.

ICON’s study team collaborated closely with networks of Huntington’s investigators on two continents to pre-identify potentially eligible patients. These networks also deployed local language coordinators on the ground in each country to support each site with 22 hours of training and expedite pre-activation activities, recruitment, and resourcing, especially with regard to certified raters. ICON also developed a management plan to acquire scale licenses, arrange for translations, and manage all tasks related to the electronic and paper-based instruments. To streamline communications and coordinate the work towards common milestones, ICON created monthly newsletters for sites and held monthly calls to discuss progress and any barriers, fostering a strong team culture across sites, sponsor, ICON and vendors.

Through ICON’s close management, the study screened 492 patients and randomised over 408 within the contracted timeline. The sponsor was so pleased with the performance that one study manager congratulated the team for the smooth and timely completion of enrollment saying, “If I could rewind time, I’d do it all over again.” Ultimately, the sponsor awarded a new project to ICON in the same indication and has selected ICON as its partner for all studies in movement disorders - a testament to the company’s satisfaction with ICON’s approach and timely delivery.