Amgen : New Programs Deliver Investigational Medicines to Patients' Homes

COVID-19 has caused significant disruptions to healthcare systems around the world, and it's not just people infected by the virus who face challenges. In many countries, the pandemic is also making it harder for people to access healthcare for other conditions. That includes patients participating in Amgen clinical trials for serious illnesses like cardiovascular disease and heart failure who may be unable visit hospitals to receive their investigational medicines.

In Amgen's Japan Asia Pacific (JAPAC) region, clinical site management teams moved quickly to find a solution that would ensure clinical trial participants continue to have access to their medicines without needing to travel to research sites in person. The result was the launch, in early April, of new Direct to Patients (DTP) programs in both China and Australia that coordinate shipments of these medicines directly to patients' homes.

'Thanks to these DTP programs, patients are now able to have their treatments delivered to their doorsteps and continue participating in our clinical trials,' says Victoria Elegant, vice president of Regional Medical for Amgen JAPAC. 'This ensures our patients can continue receiving their medications on schedule during this challenging time.'

The DTP program in China covers one cardiovascular disease study, with 314 patients on treatment. In Australia, the DTP program is available to a total of 170 patients across three studies for patients with cardiovascular disease.

As of this writing, 30 patients in the China study had expressed interest in receiving their medicines at home. Amgen's clinical site management teams in each country are currently working to inform all trial investigators about the option for home delivery of their medicines and enroll those who wish to participate.

To ensure the DTP programs comply with local regulations and guidelines for patients in both China and Australia, Amgen staff in JAPAC notified ethics committees and investigators, while coordinating with healthcare professionals, hospitals and patients, and managing the logistics of the deliveries with local courier services. Thanks to these efforts, they were able to minimize the disruption to these clinical trials and support the safety of both the patients and the healthcare professionals involved with them.

Amgen has implemented similar DTP programs in other countries and regions around the world in cases where in-home administration of the medicines is applicable, hospital and country regulations allow for DTP programs, and local doctors and hospital institutional review boards (IRB) agree home delivery is appropriate for the patients.