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. The pharmaceutical industry is continually exploring novel trial designs and methods that may alleviate the high costs and shorten study times, which can ultimately expedite new medicines to market.
In clinical trials, the Direct-to-Patient (DtP) model allows for study medications1 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 intention of this paper is two-fold:
- Provide a brief 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, including common pitfalls to consider when embarking on a DtP trial.