In 2021, I wrote a piece for International Clinical Trials called “It’s All in the Details.” The title was intentional. My argument wasn’t that Direct-to-Patient (DtP) shipments were doomed — I was careful not to predict that. What I said, at the end, was that it was “too soon to tell” whether DtP would become a lasting norm or a pandemic-era exception. Others in the industry were far more bullish, predicting that DtP would permanently redefine how clinical trials are run. Companies were created on that assumption. I was more cautious: the market was driving the narrative, and the operational details hadn’t been worked out.
A small confession about that 2021 article: it was written under a vendor’s masthead, which does tend to focus one’s prose. The questions I raised were genuine. The conclusions I didn’t quite reach were also genuine — I just kept them for conference hallways and podium Q&As, where I was fairly direct that I thought DtP was a pandemic moment, not a paradigm shift. Turns out working independently has its advantages.
Four years on, I think the cautious read was closer to right. DtP has endured — but it has endured as a selective, context-driven tool, not a dominant paradigm. And the details, as it turns out, were exactly what determined who got it right.
Reliable adoption data remain genuinely hard to pin down, and I want to be honest about that. Public registries like ClinicalTrials.gov don’t consistently tag “direct-to-patient” as a discrete category, so most available statistics conflate it with broader decentralized clinical trial (DCT) elements — telehealth, eConsent, home health nursing. What we can say with confidence is this: the overall use of decentralized elements has grown since 2020, DCT components remain a minority of global trials, and the trajectory is upward but gradual. Analysts tracking the space consistently describe adoption as real but not transformative. In short: DtP proved sustainable. It did not prove revolutionary.
1. In 2021 I Said: “Direct-to-patient delivery solves an urgent need but may not fit all trials.”
In 2021, I wrote that DtP shipments filled a critical gap during lockdowns but that the complexity might limit its routine use once sites reopened — and that sponsors should evaluate feasibility study-by-study before assuming otherwise.
In 2026, we see:
That’s exactly how it played out. DtP has become a strategic option rather than an across-the-board solution. Sponsors now deploy it selectively, often in hybrid designs that mix site visits, home-health support, and depot-to-patient delivery based on indication, geography, and patient need.
The FDA’s 2024 guidance on Conducting Clinical Trials With Decentralized Elements explicitly allows investigational product to be dispensed directly to participants in their homes — provided oversight, data integrity, and safety obligations are maintained (Federal Register, 2024-21078, September 18, 2024). Similarly, the EMA/HMA Recommendation Paper on decentralized elements urges sponsors to evaluate each element’s suitability individually and ensure it does not increase risks to participant safety, rights, or wellbeing (EMA/HMA, December 2022).
Both regulators landed, essentially, where the cautious practitioners were in 2021.
2. In 2021 I Said: “The logistics are far more complicated than they appear.”
I spent most of the original article on this point. DtP isn’t simply a new delivery address — it introduces accountability gaps, returns management, temperature control, courier compliance, and IRT system logic that must mirror site-level traceability. “Porch bandits” made it into the article. That tells you where my head was.
In 2026, we see:
The complexity remains. What’s changed is that the infrastructure has matured considerably. Select IRT/RTSM platforms now natively support depot-to-patient and site-to-patient pathways. Couriers offer validated handoff procedures and digital proof of delivery. The problem set hasn’t shrunk — but the tools to manage it are meaningfully better.
Both FDA and EMA now treat packaging, shipping, and chain-of-custody documentation as first-class considerations in decentralized trial design, requiring equivalent controls for any DtP activity (FDA, 2024; EMA/HMA, 2022).
3. In 2021 I Said: “Investigators must remain responsible for dispensing, even when the drug is shipped.”
In the original article, I flagged this as an area where regulations appeared to be lagging behind market dynamics — a point I made with some frustration. My concern was that the accountability obligations hadn’t been resolved, and that the industry was proceeding as if they had.
In 2026, we see:
That gap has been formally closed. The FDA guidance is explicit: regulatory requirements for investigations of medical products are the same whether or not decentralized elements are involved (FDA, 2024). The EMA similarly specifies that while service providers may assist in delivery, clinical-trial-specific tasks remain the responsibility of the investigator or the sponsor in accordance with ICH E6 (EMA/HMA, 2022).
What felt like regulatory lag in 2021 is now codified policy. Better late than never.
4. In 2021 I Said: “Safeguarding personal data is a unique challenge in DtP models.”
In the original, I pointed out that couriers and logistics partners often operate outside the traditional GxP ecosystem — yet they are, by necessity, handling sensitive patient identifiers and home addresses. I noted that organizations compliant with GMP might not be legally set up to hold personally identifiable information (PII), while those operating under GCP might be. The distinction matters and is often overlooked.
In 2026, we see:
The issue is still very much live — it’s just been formalized. The EMA explicitly references GDPR (EU 2016/679) as applicable to decentralized elements and requires sponsors to ensure lawful data processing and secure handling (EMA/HMA, 2022). The FDA guidance similarly highlights sponsor responsibility for data privacy and system reliability (FDA, 2024).
Formalization is progress. But what’s striking — and what the regulatory guidance doesn’t quite capture — is how differently IRT vendors have landed on this question in practice. In conversations with vendors as part of the IRT Insights Initiative, I heard the full spectrum. Some vendors are emphatic: we do not hold PII, we want no part of that journey, and DtP is a process change that happens around our system, not inside it. Others sit at the opposite end — they hold PII, own the patient-facing pathway, and have built infrastructure specifically to support it. And there’s a lot of territory in between, with vendors framing DtP primarily as a workflow and contracting challenge rather than a system capability question.
None of these positions is obviously wrong. But they have real implications for sponsors trying to evaluate IRT partners for a DtP-enabled trial. A vendor who sees this as a process change will hand you back a set of questions to answer with your courier and your legal team. A vendor who owns the pathway will hand you a solution — with its own assumptions, constraints, and commercial terms baked in. Knowing which kind of partner you’re talking to, and what that means for your program, is exactly the kind of detail that determines whether DtP works or doesn’t.
Complexity at the GMP/GCP/GDPR intersection hasn’t gone away. It’s just been distributed unevenly across the vendor landscape.
5. In 2021 I Said: “Patients may not all welcome DtP delivery.”
In the original, I cited a James Lind Care survey conducted in the UK and Denmark, which found that 24% of respondents were concerned about missing face-to-face visits with specialized medical staff in decentralized trials. That was a meaningful number — nearly one in four patients expressing hesitation about the very thing the industry was racing to implement.
In 2026, we see:
That insight still stands, and the evidence has accumulated. Studies across Europe and North America consistently show a split in patient preference: many value the convenience of home delivery and remote participation, while others prefer the reassurance of on-site engagement. Hybrid “patient-choice” models — where sponsors accommodate individual preferences rather than applying a single approach — are now widely regarded as best practice.
“If sponsors are not willing to cater to individual patient preferences, is this whole process really to the patient’s benefit — or is it really to the benefit of sponsors and those seeking a commercial opportunity?” I asked that in 2021. I stand by it in 2026.
6. In 2021 I Said: “Technology systems must evolve to support hybrid logistics.”
In 2021, I argued that traditional IRT systems weren’t built for multi-path distribution. I walked through the logic of depot-to-site, site-to-patient, and depot-to-patient flows and noted that IRT platforms had to be programmed to handle each pathway — potentially down to the individual patient level. That was a new and uncomfortable ask at the time.
In 2026, we see:
The market has moved — but not uniformly, and that distinction matters. Some IRT/RTSM vendors have built genuine native capability for hybrid distribution: multiple delivery pathways, courier integrations, and patient-level confirmation are part of their core platform. Others have moved in a different direction entirely, treating DtP as something that happens around their system rather than inside it — a process and contracting challenge for the sponsor to solve, with the IRT playing a supporting role at best.
This isn’t a criticism of either position, necessarily. But it means that “IRT systems have caught up” is too clean a summary of where things stand. The capability exists in the market. Whether it exists in your vendor’s platform is a different question — and one worth asking explicitly before you’re deep into a build. A sponsor who assumes their IRT partner owns the DtP pathway, only to discover that vendor sees it as out of scope, is going to have a difficult conversation at exactly the wrong moment in a study timeline.
Both FDA and EMA emphasize that technology must be fit for purpose, validated, reliable, and documented (FDA, 2024; EMA/HMA, 2022). That’s the right standard. Verifying that your specific IRT platform meets it for DtP — rather than assuming the market has solved this uniformly — is the due diligence the guidance implies but doesn’t spell out.
7. In 2021 I Said: “Sponsors must evaluate DtP feasibility study-by-study.”
The original article’s closing message was simple: don’t assume DtP works for your trial. Evaluate the indication, the geography, the patient population, the investigators, and the logistics before declaring yourself decentralized.
In 2026, we see:
That principle is now embedded in regulation. The EMA/HMA Recommendation Paper requires a documented risk/benefit assessment for each decentralized element, and the FDA guidance mirrors that expectation with documentation and oversight requirements for each use case (FDA, 2024; EMA/HMA, 2022).
What felt like practical common sense in 2021 is now regulatory expectation. I’ll take that as a win.
Five Years Later — The Verdict
The core thesis from 2021 holds: success in DtP delivery is all in the details.
What’s changed:
- Regulators have clarified expectations (FDA 2024, EMA/HMA 2022)
- IRT/RTSM platforms have matured — but unevenly, and the range of vendor approaches is wider than sponsors may expect
- Couriers and depots operate with defined SOPs for home delivery
- Sponsors have shifted from “should we do this?” to “how do we do this well?”
What hasn’t changed:
- Investigator oversight, documentation, and privacy still matter
- Patient preference still varies — and still needs to be respected individually
- Operational precision is still the differentiator between DtP done right and DtP done badly
- Knowing exactly what your IRT vendor does and doesn’t own in the DtP pathway is not optional
In 2021, I didn’t predict DtP would fail. I said we’d only know if it worked once we got the details right — and I said it more colorfully off the record than I did on the page. In 2026, the evidence is clear: it endured, because enough people took the details seriously. But it was never the transformation many in the industry predicted. And the companies built on that prediction have had to reckon with that reality.
It’s still all in the details. Some things don’t change.
References
1. James Lind Care, The Patient’s Perspective on Decentralized Trials (2021). jameslindcare.com/wp-content/uploads/2021/04/The-Patients-Perspective-on-Decentralized-Trials-2.pdf
2. U.S. Food and Drug Administration. Conducting Clinical Trials With Decentralized Elements: Guidance for Industry, Investigators, and Other Interested Parties. Federal Register, Doc. 2024-21078, September 18, 2024.
3. European Medicines Agency / Heads of Medicines Agencies. Recommendation Paper on Decentralised Elements in Clinical Trials. EMA/HMA, December 13, 2022. health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf
About the Author Craig Mooney is the Founder and Principal Consultant of IRT Advisors Group, an independent consultancy specializing in IRT/RTSM systems for clinical trials. He has approximately 30 years of industry experience, including as a founding employee at ICTI (later Almac Clinical Technologies), Global Head of IRT at Bristol-Myers Squibb for eight years, and a vendor-side leader at Calyx (Perceptive) and Taikun Pharma Services. He leads the IRT Insights Initiative, a structured capability asses