A large pharma company was attempting to recruit 50 patients, including 15 treatment-naive patients, in a global study for a rare pulmonary disorder. The treatment regime required weekly 1-hour infusions as well as serial PK draws and safety labs. There were recruitment challenges due to the limited patient population for this very rare disease, as well as the high burden of weekly 1-hour infusions for a 24-week treatment period. Additional challenges arose in the study design with coordinating multiple lots of the study drug, as each patient needed to receive a single lot over 24 weeks. In addition, the infusion therapy required complex reconstitution and blinding procedure.

Accellacare In-Home Services (formerly Symphony Clinical Research) provided in-home trial visits and pharmacy services to compound, dispense, deliver and administer study drug for 20 of the required 24 infusions. Our clinicians collected serial PK and safety labs at selected visits and time points, including weekend and evening visits, making the study more convenient for patients. In-Home Services were also used to capture repeat lab work for the sites and provide one-time infusions for vacationing patients.

After adding in-home clinical trial visits, enrolment was accelerated by 8 months, completing the enrolment period ahead of schedule, despite earlier delays. 59 patients were enrolled in the US alone, exceeding goals by 18%, including the 15 treatment-naïve patients.

In-Home Services was utilised by more than 80% of patients in this clinical trial. Our patient-centered services led to a shorter enrolment period of 4 months versus the projected 12-months. In addition, In-Home Services was able to perform infusions for patients while on vacation, allowing those patients to remain in the study.