Enrolling patients in clinical trials has become an increasingly challenging task. From the globalization and diversification of trials to the COVID-19 pandemic and its resultant limitations on providers and patients, the constraints on tradi-tional on-site clinical trials are more burdensome than ever.
In response to these challenges, decentralized clinical trials (DCTs) have become an increasingly popular alternative to traditional trials. These trials, which aug-ment more regimented, in-person approaches with adaptive, data-driven alterna-tives, have seen increasing adoption in recent years, galvanized by the COVID-19 pandemic and an increasing emphasis on patient-centered and at-home care.
But just as with typical clinical trials, DCTs present a number of challenges for sponsors. One of the biggest hurdles inherent to the DCT paradigm lies in ensur-ing the safety and viability of samples collected from, and treatments shipped directly to, patients. Direct-to- and direct-from-patient shipments differ from larger scale cold chain shipments in a number of ways. Finding the right contain-er and supplier to navigate the intricacies of direct-to-patient and direct-from-pa-tient shipments is critical, particularly for DCTs, bespoke biologic treatments, and vulnerable patient populations.