Direct-To-Patient Clinical Trials

Developing new drugs and medical devices is expensive, complex, lengthy, and risky. A significant portion of resources earmarked for development programs are consumed by screening, recruiting, enrolling, engaging, monitoring, and retaining patients in clinical trials. Sponsors are continually exploring methods that may minimize costs and shorten study times, but since the COVID-19 pandemic began, the focus has intensified on fundamentally changing traditional approaches to how a clinical trial is performed.

As new technologies and methods continue to drive clinical trial innovations, decentralization of many aspects of clinical trials (DCTs) has increasingly become a reality. The Direct-to-Patient (DtP) supply model is a fundamental pillar of DCTs. It has gained considerable momentum recently because it allows for study medications and/or devices to be received and administered in a patient’s home rather than at a clinical site, which offers valuable benefits to patients and sponsors alike. Furthermore, the DtP model provides you with the flexibility to design trials with virtual or hybrid (a combination of onsite and virtual) visits.

This paper provides a brief overview of factors underlying the rapid and ongoing modernization of clinical trials and provides a short discussion of DtP trials and demonstrates how they can solve some of the difficulties you may be facing today, including common pitfalls to consider in your strategy prior to embarking on a DtP trial.