Drug development is a risky endeavor that is expensive, complex, and lengthy. A significant portion of resources earmarked for drug development programs are consumed by screening, recruiting, enrolling, engaging, monitoring, and retaining patients in clinical trials. In clinical trials, the Direct-to-Patient (DtP) model allows for study medications to be received and administered in a patient’s home rather than a clinical site. The DtP drug supply model has gained momentum in recent years and continues to evolve since it can confer valuable benefits to sponsors and patients.
This paper will provide and overview of factors that drive the rapidly evolving clinical trial design landscape, and demonstrate how DtP trials can solve some of the difficulties facing drug sponsors today.