Direct-to-Patient (DTP)

1. Feb 28, 2025

What Does ‘Direct-to-Patient (DTP)’ Mean?

Direct-to-Patient (DTP) refers to a clinical trial approach where study medications and supplies are delivered directly to participants’ homes. This model eliminates the need for patients to visit clinical sites frequently, improving convenience and potentially increasing retention rates in clinical studies.

DTP services can include the shipment of investigational products, collection of biological samples, and even the administration of treatments by healthcare professionals in the patient’s home. This approach has gained popularity, especially in the context of rare disease studies and during global health crises that limit patient mobility.

Why Is the ‘Direct-to-Patient (DTP)’ Important in Clinical Research?

Direct-to-Patient (DTP) is crucial in clinical research as it addresses key challenges in patient recruitment and retention. By reducing the burden of travel and site visits, DTP models can significantly improve participant experience and compliance, leading to more robust and reliable study data.

Furthermore, DTP approaches expand the geographical reach of clinical trials, allowing researchers to include patients from diverse locations who might otherwise be unable to participate. This increased accessibility can accelerate study timelines, enhance the representativeness of study populations, and potentially lead to more generalizable results.

Good Practices and Procedures

1. Implement a robust temperature monitoring system for shipped medications, including data loggers and real-time alerts for temperature excursions.
2. Establish a dedicated patient support hotline to address concerns and provide guidance on medication handling and administration.
3. Develop customized packaging solutions that ensure product integrity while maintaining patient confidentiality and study blinding.
4. Create a secure, user-friendly electronic platform for patients to confirm receipt of shipments and report any issues or adverse events.
5. Coordinate with local healthcare providers to facilitate home visits for complex procedures or assessments that cannot be self-administered.

Related Terms

• Training Compliance
• Primary Endpoint
• Class I Device