The Direct-to-Patient (DtP) and Home Trial Support (HTS) approach places the patient, rather than the site at the center and signals an evolution in the way we deliver treatment.

The traditional patient services model

In the traditional clinical trial model, the investigator site sits squarely at the epicenter of the study, with patients, nurses and researchers all traveling inwards towards the site. It typically acts as the intermediary between the schedulers and the patient, the infusion nurse and the patient, the dispensing pharmacy and the patient, and the lab and the patient.

In the traditional approved drug treatment plan, the specialist’s office serves a similar purpose. The clinician’s office coordinates all aspects of the patient’s care, orchestrating appointments, testing and treatments to fit the providers’ schedules.

The DtP and HTS model

With the DtP and HTS approach, the patient is central with all key players revolving around him or her: sponsors, CROs, investigator sites, home nursing, labs, specialty couriers, pharmacies, drug storage facilities and packaging companies. They all play their own unique role in supporting the patient’s journey, relying on third-party logistics and nursing providers to deliver and administer the product.

In the world of clinical research (or practice) and its ‘known quantity’ of investigator sites (or ancillary medical service providers) – where staff are known, where procedures are established, where individual roles are historical, where responsibilities are clearly delineated, healthcare providers need to ask key questions:

●How do you delegate and provide appropriate oversight to third party service providers?
●How can you know that patients will receive the same level of care at home as in the clinical setting (including protection of personal information)?
●Who are the partners who will ultimately deliver these services on your behalf?

DtP and HTS are evolving the patient care delivery model – are you asking the right questions?