September 2023 Insights: greater patient centricity, shipping considerations for specialty drugs, and more
Bringing drugs to market earlier with greater patient centricity
by Andrea Zobel
The increasing demand for diversity and inclusion in clinical trials, and the need to reach patients wherever they may be, is now being addressed with the help of direct-to-patient (DtP) shipments. In a recent podcast, Andrea Zobel, Senior Director of Personalized Supply Chain discussed how the industry is shifting towards a more patient-centric approach, streamlining the clinical trial process, and bringing life-saving drugs to market faster.
What are DtP shipments?
DtP shipments refer to the practice of shipping clinical trial materials directly to a participant’s home. This model makes it easier for patients to partake in clinical trials by decentralizing them, and in particular for those with health conditions that may hinder their ability to visit clinical trial sites. Direct-to-patient shipments extend the clinical trial environment to patients' homes, increasing accessibility and participation, improve participant retention, and can bring medicines to those most in need.
This concept is not new though. In fact, it gained significant attention during the pandemic when clinical trials could not proceed without remote strategies. The method of direct-to-patient shipping improved patient enrollment, reduced dropout rates, and increased diversity in clinical trials.
Key considerations for executing a decentralized trial
Three crucial factors must be considered in direct-to-patient shipments:
Addressing these challenges
Technological advancements can help overcome many of these challenges. Real-time tracking, secure data transmission, and temperature-controlled packaging are all solutions that can be leveraged to improve DtP shipments. However, the absence of specific regulations for DtP shipments remains a challenge. It is important for the industry and regulatory bodies to work together to establish robust legislation that accommodates this patient-centric model.
The future of direct-to-patient
The adoption of a DtP model for executing decentralized clinical trials is expected to increase. With the right regulations, technological advancements, and an emphasis on patient centricity, this method can revolutionize the conduct of clinical trials.
Key takeaways
The ultimate goal of decentralized trials is patient centricity. By improving accessibility and diversity, this method not only benefits the participants but can also help bring life-saving drugs to the market faster for the benefit of all patients
It's got to be cold, fast, and efficient
What to consider when selecting shipping for your specialty drug product
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Demand for advanced cold-chain logistics is increasing as more and more treatments, from vaccines to cell and gene therapies (CGTs), are requiring complex temperature-controlled transport and storage. With the right logistics supplier, it is possible to implement an effective cold-chain supply strategy to meet your unique needs. But how do you find the best logistics partner? What actions are needed to fully understand the capabilities of potential suppliers?
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Six considerations when bringing your new product to market
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