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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.

DOWNLOAD DIRECT TO PATIENT CASE STUDY

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

Elizabeth Gallagher