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 traditional 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 augment more regimented, in-person approaches with adaptive, data-driven alternatives, 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 ensuring 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-patient shipments is critical, particularly for DCTs, bespoke biologic treatments, and vulnerable patient populations.