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Direct-to-Patient Trials: Opportunities and Challenges

Elizabeth Gallagher

By: Elizabeth Gallagher May 25 2018

Tags: Clinical Supply Optimization, Global Distribution, Logistics for Clinical Trials, Transportation

Direct to Patient Considerations

There could be no better example of patient-centricity than direct-to-patient (DTP) clinical trials. It eliminates the need for a patient to travel to an investigator site because medication is delivered directly to the patient’s home.

Opportunities of the DTP model

  • Patient convenience, particularly those who are non-ambulatory, lack transportation or live in remote locations.
  • Patient cost savings associated with eliminating travel to an investigator site.
  • Higher engagement and retention rates for the trial sponsor.
  • Supply chain efficiencies by reducing the number of handoffs and investigator site costs..

Challenges of the DTP model

  • There is little regulatory guidance on designing and executing DTP studies, with rules varying from country to country.1
  • Patients can be reluctant to self-administer in particular when working with injectable drugs, and it can be difficult to ensure they have taken the required dosage on schedule.
  • Coordination with a healthcare professional may be required to administer the drug.
  • When working with temperature sensitive product, cold-chain supplies must be shipped to remote and often difficult-to-find locations in temperature-controlled packaging.
  • Ensuring the drug is stored properly at the patient location can be costly and challenging.
  • Sponsors often contend with greater transportation costs, thanks to a high volume of small shipments and the reverse logistics of shippers and biological specimens.
  • Studies still need to be managed centrally by a remote study coordinate center.

Only a small percentage of today’s studies use this model across the entire trial. In some cases, sponsors are offering a DTP service as an 'exception' process when unexpected events interfere with a patient keeping their scheduled appointment.

We encourage sponsors engage their suppliers to review the possibilities on a trial-by-trial basis. There may be opportunities to test the Direct to Patient concept as an exception process, or in a controlled sub-set of the overall clinical trial that can be closely managed and monitored for future expansion.


1. Covington, Deborah and Veley, Kristin. “The Remote Patient-Centered Approach in Clinical Research.” 12 January 2017.

Elizabeth Gallagher