The enrollment was completed for a phase IV, multicenter, randomized, non-inferiority trial by reaching the study-wide goal of including 360 patients. GCT is responsible for managing project in Russia where the patient enrolment began in August 2020.
From the start of the trial, Russian sites selected by GCT showed an encouraging recruitment rate resulting in the decision to open additional sites in the country. Initially, Russian sites were to recruit 156 out of 356 subjects in the study with the enrollment being competitive between 3 countries. While the recruitment in other countries dropped due to the global pandemic, GCT Russian team rescued the study by eventually enrolling 256 instead of 156 patients.
“We are proud of the recruitment speed that the sites in Russia were able to achieve, despite the pandemic. Strategic partnerships between sponsors and CROs assuring the most effective patient enrollment approach is implemented, and the important milestones are achieved on time or beforehand,” said Jeffrey T. Apter, GCT President.