An American biopharmaceutical company focused on researching and developing antiviral drugs was conducting Combined Phase2b/3, double-blinded, randomized placebo-controlled studies evaluating the Efficacy and Safety of IMP in the induction and maintenance of remission in moderately to severely affected patients in India.
Due to the COVID-19 pandemic outbreak in mid-2020, enrolled patients could not come to sites due to nationwide lockdown measures in India. To avoid trial disruption and ensure that patients continued to receive treatment, this company needed support and solutions for delivering the IMP with complete temperature integrity and urgency from sites to patients’ homes.
India with its vast geography and demographic diverse locations, unfavourable infrastructure, and connectivity to far-flung remote locations where trail, road, and air services were closed, posed a very critical challenge for delivering the IMP from clinical sites to patients by employing Direct-to-Patient (DTP) service in required temperature ranges and within the required timelines. These clinical sites, comprise mostly of hospitals in metro locations like Mumbai, Delhi, Bangalore, etc.
Despite all odds and restrictions on the movement of people and vehicles for inter and intrastate transfers, Yourway managed to create solutions that allowed the delivery of these investigational medicines during the nationwide lockdown in place due to the COVID-19 pandemic, special permissions were obtained from local police and other government agencies for Yourway vehicles to transport these life-saving investigational medications, ensure delivery of IP to patients located in cities as far as Yawatmal in Maharashtra, Ruby Medical Hall Pune, and Gaya in Bihar from AIIMS Hospital in New Delhi. Yourway deployed dedicated vehicles and experienced trained staff to effectively execute DTP shipments around the clock. GDPR rules and local regulations were properly followed, ensuring the completion of required patient forms supported by Yourway proven expertise and robust ready-to-use validated passive packaging solutions equipped with data loggers to transport materials requiring temperature-controlled management of various temperature ranges ( -180°C, -80°C, -20°C, +2°C to +8°C and +15°C to +25°C). As a result of the solutions put in place by Yourway’s experienced staff, patients were able to receive their treatment timely per the dosing schedule prescribed in the study protocol.
We have seen remarkable acceleration in the adoption rate of decentralized clinical trials. DTP/DFP (Direct-to-Patient/Direct-from-Patient) models for the distribution of IP and biological specimens. CRO/Pharma Sponsors, since the onset of the COVID-19 pandemic, have relied more on this model, and many believe DCT to be the future preferred method due to its many benefits: reduction of patient study dropout rate, increased protocol compliance, and enhanced patient-centricity associated with the delivery of a “virtual hospital experience” at the comfort of the patients’ homes.
Author: Syed Nasar Hasan Rizvi
General Manager – Yourway India