In 2022 I wrote that the U.S. recruitment crisis — not cost — was driving clinical trials overseas. Four years later, the question has matured: it is no longer whether to go overseas, but where, and how the data comes home.
September 30, 2026
8
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
First-in-Human
Latin America
FDA
Early Feasibility Studies
Medical Devices
Clinical Research
In short
U.S. companies run first-in-human trials overseas primarily because of the recruitment crisis at home — enrollment throughput, not just cost. Writing in 2022, Julio Martinez-Clark reported that 52% of global clinical trials took place outside the U.S., that 35% of trial delays traced to lack of subject recruitment, and that Latin America’s dropout rates were one-third of U.S. and EU rates. In 2026 the decision is strategic: U.S. EFS when early FDA interaction matters most, Latin America FIH when activation speed and enrollment throughput matter most — and under 21 CFR 812.28 the FDA accepts the overseas data back into a U.S. IDE or Breakthrough Device strategy.
The source article. This post is a 2026 update of “Latin America: A Compelling Region To Conduct Your Clinical Trials”, published on Med Device Online on June 7, 2022. Every figure below attributed to that article is explicitly its 2022 vintage — the point of this update is what still holds and what changed.
What the 2022 article established
The 2022 article made an argument that ran against the conventional wisdom of the time. The standard story was that U.S. companies offshored clinical trials to save money. Writing in 2022, I argued that the main driver was something else entirely: the recruitment crisis in the home country. Studies had challenged the traditional thinking of cost-related factors as the primary reason for offshoring, and shown the importance of the recruitment of human subjects in trials.
The article laid out why recruiting subjects in the U.S. is so difficult: fewer people feel the need to participate, the standard of care is higher and costlier, busy specialists are unwilling to dedicate time to unproven products, HIPAA’s privacy rule adds uncertainty and delay, and the availability of alternative FDA-approved palliative options makes subjects think twice — especially in phase I or first-in-human studies.
And it put industry numbers behind the claim. Writing in 2022, citing industry data available at the time: 35% of trial delays were due to lack of subject recruitment, nearly one-fifth of investigators did not enroll any subjects, and about one-third of investigators enrolled only 5% of eligible subjects. As a result, ClinicalTrials.gov showed that 52% of global clinical trials took place outside the U.S. Those were 2022 figures — but the structural forces behind them have only intensified.
That is the thesis nobody on the internet has owned since: U.S. companies don’t go overseas for first-in-human trials because they are cutting corners. They go because the patients aren’t enrolling at home.
What the 2022 data said about Latin America
The 2022 article then made the case for Latin America specifically, and the numbers — again, explicitly the 2022 vintage — were striking:
- Scale. Latin America supported about 10% of clinical research worldwide, per FIFARMA figures cited in 2022.
- Device-trial growth. In 2020 there were 31 medical device trials in Latin America — a 138% increase from 17 in 2017. About 1% of global medical device clinical trials happened in the region.
- Retention. Experts agreed that dropout rates in Latin America were one-third of those in the U.S. and the EU — a direct consequence of strong doctor-patient bonds, large urban catchments, and motivated participants.
- Colombia as the proof point. Nearly 52 million people (80% urban), a WHO healthcare ranking of 22 out of 191, a rigorous level-4 regulatory agency in INVIMA, 135 certified research centers, 76 certified ethics committees — and the only country in Latin America with GCP institutional-level certification.
The through-line of the 2022 piece: Latin America wasn’t a discount destination. It was an enrollment destination — dense urban populations, motivated investigators eager to publish, and retention economics that beat the U.S. and EU.
What changed by 2026
Four years on, the 2022 diagnosis holds up. What changed is the shape of the question — and the strategic context around it:
| 2022 | 2026 | |
|---|---|---|
| The question sponsors ask | “Should we go overseas?” | “Where — and how does the data come home?” |
| The primary driver | The recruitment crisis at home | The recruitment crisis, plus strategic FDA positioning |
| The U.S. option | Barely in the frame for early FIH | FDA’s Early Feasibility Study program, growing toward “EFS 2.0” — FDA explicitly wants early U.S. clinical experience |
| The data path home | Implied | A designed-for pathway: 21 CFR 812.28 |
The most important shift is the last two rows taken together. FDA’s Early Feasibility Study program is growing toward what the agency conversation now calls “EFS 2.0” — FDA explicitly wants early U.S. clinical experience with novel devices. That doesn’t invalidate the overseas first-in-human; it makes the U.S.-versus-OUS decision strategic rather than merely cost-driven. Sponsors now choose deliberately, program by program, instead of defaulting to one geography.
From “should we” to “where, and how does the data come home”
Here is the 2026 pattern we see across programs: sponsors reach first-patient-in in Latin America — where activation runs in weeks and enrollment throughput is the structural advantage — and then bring the resulting dataset back into their U.S. regulatory strategy. Under 21 CFR 812.28, the FDA accepts data from clinical investigations conducted outside the United States when they are run under good clinical practice with adequate documentation and monitoring. Offshore first-in-human data supporting a U.S. submission is a designed-for pathway, not a workaround.
So the dataset generated overseas returns home to support an IDE or a Breakthrough Device submission. The overseas stage buys time and evidence; the U.S. stage remains the destination. That repatriation step — barely discussed in 2022 — is now the center of the conversation.
A concrete illustration of the activation side of this pattern is the case we documented in the sponsor that lost three years in Australia before moving its first-in-human program to Panama and El Salvador: the stall was never the regulator, it was activation and enrollment — the same two terms the 2022 article identified.
The honest geography-selection framework
If the 2022 article answered why companies go overseas, the 2026 update has to answer where — honestly, because the answer differs by program:
- Choose U.S. EFS when early FDA interaction and U.S. site experience matter most to the program — early feedback on the device and the clinical plan from the agency that will review the marketing submission. See our early feasibility studies overview and U.S. execution approach.
- Choose Latin America FIH when activation speed and enrollment throughput matter most — first-patient-in measured in weeks, dense urban catchments, and retention economics the 2022 article documented. See our first-in-human CRO services.
Our position, stated plainly: bioaccess advises on U.S. EFS versus Latin America FIH strategy from Miami and executes first-in-human trials across 19 Latin American and Caribbean countries. We tell sponsors honestly which geography their program needs rather than selling one answer — because the 2022 thesis was never “always go overseas.” It was “go where the patients are, and bring the data home.”
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