Bringing drugs to market earlier with greater patient centricity

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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:

1. Adherence to good clinical practice.
2. Ensuring data privacy.
3. Maintaining the integrity of the investigational medicine product (IMP) during transit.

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