April 17, 2025
Direct-to-Patient
The Direct-to-Patient Model: Investigative Sites Are Ready—Are You?
In the evolving world of clinical trial operations, one thing is clear: Direct-to-Patient (DTP) drug shipments are no longer a fringe innovation—they’re quickly becoming a strategic imperative. A 2025 study commissioned by the Global Clinical Supplies Group (GCSG) and conducted by the Tufts Center for the Study of Drug Development sheds new light on how investigative sites view this decentralized model.
The findings? Sites are overwhelmingly open to DTP—but they need support.
Key Insight: Sites Are Willing, But Want a Say
Nearly 87% of U.S.-based investigative sites surveyed reported they are receptive to participating in trials that use DTP drug shipments. And two-thirds already have hands-on experience with either site-to-patient (STP) or warehouse-to-patient (WTP) delivery models.
However, even with growing familiarity, most sites (68%) still say they prefer traditional IP distribution through on-site visits. Why? The answer isn't resistance—it’s risk and burden. Without clear protocols and support structures, sites feel the weight of compliance, patient oversight, and logistical complexity falling on their shoulders.
What Makes DTP Attractive
Sites believe DTP positively impacts patient willingness to join and stay in trials. Oral and topical study drugs are seen as highly feasible for home delivery, and sites reported a tangible boost in enrollment and completion rates. One standout metric: nearly 60% of sites said DTP shipments improved trial completion ratios. That kind of patient-centric efficiency translates directly into faster timelines and cleaner data.
Tufts’ modeling shows that DTP shipments could reduce enrollment time by up to 45 days—translating to a potential $2.5M in savings for Phase III trials. That’s a 40% return on investment when accounting for direct DTP costs alone.
What’s Holding DTP Back?
Despite the enthusiasm, investigative sites flagged several operational pain points:
Increased Workload: Sites reported higher demands for patient follow-up, training, and tech support.
Privacy & Safety Concerns: Over one-third of sites said DTP raises issues around safeguarding patient data and ensuring safe drug delivery.
Logistical Oversight: Gaps in inventory tracking, inconsistent shipping records, and lack of delivery confirmation mechanisms create compliance headaches.
As one respondent put it:
“Shipping centers don’t send records to research sites, which creates major oversight challenges.”
What Sponsors Can Do
Sponsors embracing DTP must do more than just flip the logistics switch. The study offers three clear recommendations to improve site buy-in:
Include site input early in protocol design—especially for DTP-heavy trials.
Train site staff and patients upfront, not midway through enrollment.
Invest in IP tracking and communication tools that reduce administrative drag.
Bottom Line
The data shows the value of DTP isn’t just hypothetical. Sites are ready. Patients are receptive. And sponsors stand to gain measurable speed and cost advantages. But for DTP to scale, sponsors need to shoulder the complexity—not shift it to sites.
At OnPoint Trial Supply, we help biotechs build DTP-ready clinical supply strategies that reduce risk, improve patient experience, and streamline site collaboration. Ready to make the shift from pilot to platform?
Let’s optimize your supply chain—direct to patient, direct to impact.