Phase I Trials in Serbia: What the Data and Practice Show
- Pavel Shkliaev
- May 6
- 1 min read
There is a persistent belief in clinical development that Phase I studies are impossible or prohibited in Serbia. Recent discussions with local experts paint a very different picture.
Phase I trials are approved in Serbia — and they are already being successfully conducted. Regulatory and ethics review is strict and thorough, but once approved, sites operate at international standards. This sets a strong precedent for future early-phase submissions.
Why Serbia deserves more attention for Phase I studies:
🔹Opportunity for early-phase research. For several oncological diseases, treatments available in other countries are not routinely accessible in Serbia, creating a suitable environment for early-phase trials. It also makes Serbia particularly attractive for studies requiring therapy-naive populations.
🔹 Well-equipped and operationally ready sites. Sites perform comprehensive diagnostics. For example, for oncology studies it includes morphology, flow cytometry, cytogenetics, PCR/FISH, NGS, and MRD assessment — supported by dedicated molecular biology teams.
The takeaway
Serbia remains an undiscovered location for Phase I oncology trials.
For patients: access to therapies not otherwise available locally.
For practicing clinicians: the opportunity to participate in early-phase research and gain hands-on experience with novel therapies.
For sponsors: an alternative strategy for sites with sufficient patient populations and operational readiness, especially where Western markets are saturated or enrollment is slow.
Expert Network exists to surface realities that don’t always show up in feasibility spreadsheets.
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