PRACTICAL GUIDE | 2026
Enrollment plans built from site flow, not headlines.
By Julio G. Martinez-Clark
CEO, bioaccess®
Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.
| Suggested URL slug | latam-fih-patient-recruitment-feasibility |
|---|---|
| SEO title | Patient Recruitment for FIH Trials in Latin America: Feasibility Numbers | 2026 Guide |
| Meta description | How FIH enrollment is really modeled in LATAM: ~1 patient/month planning, 1–3 month KOL qualification, weekly recruitment management, and backup-site strategy. |
| Suggested excerpt | Population statistics don't enroll patients — investigators do. Here are the feasibility numbers bioaccess® actually uses to model FIH enrollment across Latin America. |
Sponsors model recruitment from population statistics. We model it from the clinic's waiting room. Patient recruitment for FIH trials in Latin America is a feasibility exercise, not a demographics exercise — and the feasibility numbers look different from the headlines. These are the planning figures behind the enrollment models we defend to sponsor boards, drawn from client questions we have answered since 2021.
- bioaccess® — a first-in-human (FIH) contract research organization (CRO) running early-stage clinical trials across Latin America.
- FIH (first-in-human) — the first clinical use of a device or drug in people — typically a small, closely monitored early-feasibility study.
- KOL (key opinion leader) — a recognized clinical expert whose practice, referrals, and reputation drive patient flow for a trial.
- First patient in (FPI) — the enrollment of the first trial participant — the milestone that starts the enrollment clock.
- Inclusion/exclusion criteria — the protocol's rules defining exactly which patients may and may not enroll.
How is enrollment actually modeled?
From actual site patient flow — the number of eligible patients the investigator sees per month — not from the country's population or the disease's prevalence. Investigator interest beats demographics: a motivated investigator with a real referral network in a mid-size city out-enrolls a disengaged department in a capital. The planning figures below come from questions sponsors have asked us across calls and email since 2021.
| Milestone | Planning figure | What it assumes |
|---|---|---|
| KOL identification and qualification | 1–3 months | Finding and vetting the right investigators in the chosen country. |
| Approval to first inpatient | About 1 month after approval | Regulatory approval in hand, site activated, first patient enrolled. |
| Steady-state enrollment | About 1 patient per month (conservative) | FIH-eligible patients under narrow inclusion/exclusion criteria. |
| Recruitment management cadence | Weekly | Standing meetings with the site to find and clear roadblocks. |
Why is the planning rate only about one patient per month?
First-in-human inclusion and exclusion criteria are narrow by design. The eligible patient is a subset of a subset: the right diagnosis, the right anatomy, the right stage — and willing to consent to an experimental device or drug. One patient per month is the conservative planning figure we will defend to a board. Actual enrollment often runs faster, but budgets and timelines should be built on the number we can stand behind, not the number we hope for.
Does investigator interest really beat demographics?
Yes. When sponsors ask how easy it is to find another bolus of patients mid-study, the answer has three parts: it depends on the investigator, the inclusion/exclusion criteria, and the healthcare system — in that order. The investigator comes first. There is also a structural factor no population table captures: in countries where public-system access is poor, patients are forced to look for trials. Clinical research becomes a genuine care pathway, not a last resort — a real enrollment dynamic, and one more reason patient recruitment for FIH trials in Latin America rewards on-the-ground feasibility over desk research.
What happens when enrollment stalls?
Our job is to recruit patients. We meet with the site every week, find the roadblock, and clear it. Sometimes the roadblock is clinical — referral patterns, screening failures. Sometimes it is logistical — including the US proctor's schedule, which has to align with the procedure date. Weekly management is the difference between an enrollment plan and an enrollment result.
The feasibility checklist: what we confirm before quoting enrollment
- Actual patient flow at the specific site — not national prevalence figures.
- The investigator's demonstrated interest and referral network.
- KOL qualification completed (1–3 months) before activation planning begins.
- Inclusion/exclusion criteria tested against real patient charts, where possible.
- Backup sites prequalified before first patient in — activation becomes a decision, not a project.
- Proctoring schedules aligned with the procedure calendar.
- A weekly recruitment-management rhythm with named owners on both sides.
Frequently asked questions
How long does it take to qualify KOLs in the chosen country?
One to three months: identifying candidate investigators, vetting their practice and patient flow, and confirming genuine interest in the study.
When should we expect the first inpatient?
About one month after regulatory approval — approval in hand, site activated, first patient enrolled.
What enrollment rate should we plan for?
Conservatively, about one patient per month. FIH criteria are narrow by design; plan on the number we can defend, not the number we hope for.
If we need another bolus of patients mid-study, how easy is it?
It depends on three things, in order: the investigator, the inclusion/exclusion criteria, and the healthcare system. That is why backup sites are prequalified up front.
Why would poor public-system access help recruitment?
Because it forces patients to look for trials — clinical research becomes a real care pathway. Sponsors should treat these patients with the same ethical rigor as any trial population; the point is about access dynamics, not about lowering standards.
Do you manage the US proctor's schedule as part of recruitment?
Yes. Proctor scheduling is part of weekly recruitment management — a misaligned proctor is a stalled enrollment, and we treat it as our roadblock to clear.
Build your enrollment model on real site flow
bioaccess® qualifies investigators, models enrollment from actual patient flow, prequalifies backup sites, and manages recruitment weekly — across Latin America. Bring us your protocol; we will tell you what the feasibility numbers actually look like.
Talk with bioaccess® about your Latin America FIH strategyTalk with bioaccess® about your Latin America FIH strategy
References
- Planning figures in this post reflect bioaccess® client programs and sponsor Q&A, 2021–2026 (all clients anonymized).
- Related reading: “Patient Recruitment Strategies in Chile for Clinical Trials Success” (bioaccessla.com blog) — a Chile-specific companion to this LATAM-wide FIH framing.
- General: confirm enrollment planning assumptions against the final protocol and the qualified sites before committing timelines.
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