Direct-to-Patient Clinical Supply: When DtP Models Make Sense (and When They Don't)

Direct-to-patient (DtP) supply means shipping investigational product from a depot, pharmacy, or site directly to the patient's home rather than requiring every dose to be dispensed in person at the clinical site. Done well, DtP widens recruitment, protects retention, and makes decentralized trial designs viable. Done casually, it multiplies your temperature excursions, complicates accountability, and creates regulatory exposure across every jurisdiction you ship into. The difference is design.

Why are sponsors adopting DtP at all?

Because the patient's burden is the trial's bottleneck. Site-visit burden is a leading driver of dropout, and dropout is among the most expensive failures in clinical development — every lost patient represents sunk recruitment cost and statistical power. DtP shrinks that burden: fewer trips for patients who are elderly, immunocompromised, rural, or simply employed. Sponsors also gain reach — a trial that ships to the patient can recruit far beyond the catchment radius of its sites, which matters enormously for rare disease programs where eligible patients are scattered across continents.

Which trials are good candidates for DtP — and which aren't?

Strong candidates share a profile: stable, self-administered products (oral solids, pre-filled syringes, pens); long treatment durations where visit fatigue accumulates; rare disease and geographically dispersed populations; and protocols already designed around remote monitoring.

Poor candidates: products requiring infusion or clinical administration, very short-stability or complex cold-chain products where the last mile is the riskiest mile, dosing that depends on same-day clinical assessment, and early-phase studies where tight PK sampling anchors patients to the site anyway.

Most programs land in between — which is why the dominant real-world model is hybrid: site visits at anchor points, DtP shipments in between.

What are the supply chain implications sponsors underestimate?

Four recur in nearly every DtP program we assess:

• The last mile owns your stability budget. A depot-to-site lane is professional on both ends; a depot-to-doorstep lane ends at a porch in summer. Shipper qualification, monitoring, and delivery-window management have to be engineered for the home, not the loading dock.
• Accountability gets harder, not easier. Drug accountability, returns, and destruction now involve patients' homes. The reconciliation process — what shipped, what was used, what comes back — must be designed into the protocol and the IRT from day one, not retrofitted.
• Blinding travels with the box. Labels, packaging, and even shipper configuration must preserve the blind at a kitchen table, without a pharmacist intermediary.
• Every destination is a regulatory jurisdiction. Who may ship medicine to a patient's home — and from where, and with whose pharmacy license — varies by country and, in the US, by state. A DtP design that's compliant in one market can be illegal in the next; the shipping matrix needs regulatory mapping before it needs couriers.

How should a sponsor design a DtP-ready supply strategy?

Sequence it: (1) segment the protocol — which visits truly need the site, which doses can ship; (2) map the regulatory pathway per market, including pharmacy-of-record and importation models; (3) qualify the last-mile lane like any other lane — shippers, couriers, seasonal profiles, delivery confirmation; (4) integrate DtP logic into the IRT so shipments, returns, and resupply triggers are systematized; and (5) pilot in one or two markets before scaling.

Sponsors who treat DtP as a courier decision get courier-grade results; sponsors who treat it as a supply chain design decision get retention numbers worth publishing.