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.” AppliedClinicalTrials.com. 12 January 2017.