Alternatives to Australia for First-in-Human Trials: 2026 Decision Guide
Five questions decide where your first-in-human study should run. For some sponsors the honest answer is Australia. For most, it is Latin America — and the FDA-acceptance record explains why.
September 8, 2026
8
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
Australia
Latin America
First-in-Human
FDA
Panama
Medical Devices
What does Australia genuinely get right?
Start with the concession, because a decision guide that only argues one way is not a guide. Australia offers three real advantages: a genuine refundable R&D rebate at 43.5%, a fast TGA notification pathway, and clinical data quality that reviewers trust. None of that is marketing. Sponsors choose Australia for defensible reasons.
We say this plainly because the failure mode we see is not sponsors picking Australia — it is sponsors picking Australia for the rebate without checking the eligibility conditions, the payout timing, or whether their catchment can enroll the study. The rebate math is unpacked in the true cost of Australia's 43.5% R&D tax incentive, and the notification-versus-first-patient-in distinction in TGA CTN vs. Latin America first-patient-in timelines.
Which sponsors should just stay in Australia?
Some. Specifically:
- You are already an Australian-resident company under the A$20M turnover cap, so the 43.5% refundable rebate applies to you without standing up a new entity.
- Your study does not need representation across the full Fitzpatrick I-VI phototype range.
- Your protocol does not depend on large, fast enrollment — a small cohort over a longer window is acceptable to your board and your runway.
If all three describe you, stop reading and run in Australia. That is the right answer, and pretending otherwise would cost you money.
Why concede this much? Because the sponsors who convert are the ones who trust the framework. If the framework never says "stay in Australia," it is a sales script, not a decision tool.
How do you choose a first-in-human country in 2026?
Run these five questions in order. The first one that produces a hard constraint decides your geography.
| Question | If yes | If no |
|---|---|---|
| 1. Are you already Australian-resident and under the A$20M turnover cap? | The 43.5% rebate may favor staying in Australia. Weigh it against payout timing before committing. | The rebate requires an Australian entity you do not have. Keep going. |
| 2. Do you need the full Fitzpatrick I-VI phototype range? | A single-country Australian cohort cannot supply it. A multi-arm Latin America design can. | Phototype range is not a constraint for you. Keep going. |
| 3. Do you need first-patient-in fast? | Compare on activation and enrollment, not notification speed. Latin America activates quickly. | A longer window is acceptable. Keep going. |
| 4. Does dense catchment matter to your enrollment plan? | Population density around your sites is the rate limiter. Latin American metros are denser. | Your cohort is small enough that catchment is not binding. Keep going. |
| 5. What is your travel and time-zone tolerance? | If your team must attend early procedures, working-hour overlap and flight time are real costs for US-based sponsors. | If your team will not travel, this question does not bind. |
Question two is the one most sponsors underweight, and it is the least fixable. The reasoning is in Fitzpatrick I-VI skin-type diversity in clinical trials. Question four is arithmetic, not opinion — see the Australian catchment math.
Where does the framework land for most sponsors?
For sponsors who need speed to first-patient-in, full phototype diversity, dense catchment, and who do not have an Australian entity, the framework lands on Latin America with bioaccess®. That is not a preference; it is what the five questions produce when the answers are speed, diversity, density, and no entity.
What that looks like operationally: a first-in-human CRO handling regulatory submission, ethics, sites, monitoring, and import/export as one scope; country programs such as Panama for fast activation; and market access work sequenced so the clinical data you generate also supports registration later. For the sponsor who waited too long to make this call, the pattern is documented in we lost three years in Australia. The full head-to-head sits in the pillar: Australia vs. Latin America for first-in-human medical device trials.
Will the FDA accept data from outside the US?
Yes, and this is the objection worth answering carefully, because it is the one that stalls decisions. Under 21 CFR 812.28 — the final rule issued in 2018 — the FDA accepts clinical data conducted outside the United States when the study was conducted under good clinical practice. Acceptance is by design. It is written into the regulation, not negotiated study by study.
Read that as a design instruction rather than a loophole. If the GCP conditions are met in how the study is run, monitored, and documented, geography is not the variable that decides whether your data count. What decides it is whether the trial was run to the standard the rule names.
Which programs prove the pathway works?
Industry-wide precedents, none of them ours:
- MitraClip — the world's first human implant took place in Caracas, Venezuela in June 2003 (Dr. Jose Condado). FDA approval followed in October 2013. It is now a global standard of care.
- Tendyne TMVR — first-in-human in Paraguay (Dr. Adrian Ebner) under an FDA-issued 801(e) export permit. FDA PMA approval 27 May 2025 (P240042).
- CereVasc eShunt — first-in-human in Buenos Aires in 2021 (Dr. Pedro Lylyk, ETCHES I study) under ANMAT, followed by two FDA IDE approvals plus Breakthrough Device designation in August 2024 (NCT05250505).
And three public bioaccess® client programs:
- ReGelTec HYDRAFIL — first-in-human in Colombia, 20 patients, 2020, then FDA Breakthrough Device designation in December 2020 and a US IDE (NCT04984629).
- enVVeno VenoValve — first-in-human in Colombia, 11 patients, then the US pivotal SAVVE study and PMA path.
- PAVmed PortIO — Colombia, approval in 5 weeks, results published in the Journal of Vascular Access.
The common structure across all six is the same: generate the earliest human evidence where it can actually be generated, to the standard 21 CFR 812.28 names, then take it into the US pathway. That is the pattern the decision framework is pointing you toward.
Frequently asked questions
What is the fastest next step?
Send us your protocol synopsis, your cohort size, your phototype requirement, and your target first-patient-in date. We will run the five questions against your program and tell you honestly whether Latin America is the right answer for you. Get a first-in-human feasibility read in 72 hours.
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