Direct To Patient (DTP) Clinical Trials

With more and more studies focused on disperse patient populations, the industry has been exploring alternative trial designs to improve enrollment and ease the burden on patients to access trial sites. One of these alternative designs is Direct-to-Patient (DtP).

DtP trials are a win-win for patients and sponsors. Patients gets better service, travel less, get their treatment where they are and sponsors accelerate trial timelines and reduce cost. The challenge lies in designing it correctly so the integrity of the study remains intact - such as addressing significant impacts on the supply chain, including timing, shelf-life and temperature.

The purpose of this white paper is to provide in-depth information on the various DtP approaches while offering insight into best practices when incorporating DtP into the protocol. Additionally, resulting supply chain challenges are explored as well as how Randomization and Trial Supply Management (RTSM) systems can be leveraged to overcome those challenges.