TL;DR:
Expenses depend on the trial phase, therapeutic area, and program length.
Sertkaya and colleagues (2016, Clinical Trials), in a study commissioned by the US Department of Health and Human Services, provide a phase-by-phase breakdown for industry-sponsored trials: Phase I ranges from $1.4M to $6.6M, Phase II from $7M to $19.6M, and Phase III from $11.5M to $52.9M. The wide ranges within each phase reflect therapeutic area variation: an oncology Phase II costs more than a dermatology Phase II because it requires more complex endpoints, more monitoring visits, and more intensive safety oversight.
Moore and colleagues (2018, JAMA Internal Medicine) analyzed 59 drugs: the pivotal trials cost a median of $19M in the US, with half of trials falling between $12M and $33M. This figure reflects only the cost of the final trial before approval, in most cases Phase III, sometimes also Phase II, not the full development arc.
Capturing the full arc, the ASPE/HHS Drug Development report (2024) estimates that the average clinical trial expenditure per approved drug reached $172.7M. The report breaks total drug development cost into four parts: non-clinical stage ($11.8M), clinical phases 1 through 3 ($117.4M), which represents 68% of total out-of-pocket R&D costs, FDA submission ($2.6M), and post-approval Phase 4 studies ($40.9M). However, where you run the trial and how you design it, affects the total cost too.
| Phase | Lower End (Sertkaya et al., 2016) | Higher End (ASPE/HHS, 2024) | Average |
|---|---|---|---|
| Phase I | $1.4 M | $7.1 M | $4.25 M |
| Phase II | $7 M | $21.0 M | $14.0 M |
| Phase III | $11.5 M | $89.3 M | $50.4 M |
Yes, Western and Central European sites cost approximately 50% of North American equivalents per site.
The precise figures, however, are harder to find than most sources suggest. A systematic review by Speich, von Niederhäusern, and colleagues (2017, Journal of Clinical Epidemiology) found that no published study provides comprehensive empirical cost data for industry-sponsored randomized clinical trials in the EU. The most rigorous peer-reviewed comparison of EU versus US costs remains Qiao, Alexander, and Moore (2019, Clinical Trials), who applied IQVIA’s CostPro model to the pivotal trials supporting FDA approvals in 2015 and 2016. Their main finding: Central European sites cost a median of 50% of North American equivalents on a per-site basis.
For the comparison above, Central and Eastern Europe (CEE) includes the Czech Republic, Poland, Hungary, Romania, Bulgaria, Slovakia, Slovenia, Croatia, Estonia, Latvia and Lithuania. Western Europe includes Germany, France, the Netherlands, Belgium, Spain, Italy, Austria, Portugal, Ireland, Luxembourg and Greece.
| Phase | CEE | Western Europe | United States |
|---|---|---|---|
| Phase I | $1.54M | $3.25M | $4.25M |
| Phase II | $10.75M | $13.68M | $14.00M |
| Phase III | $21.15M | $19.00M | $50.40M |
These figures show that Europe can offer a substantial cost advantage, particularly in Phase I and Phase III. The calculations are based on completed single-country trials; in practice, EU-based studies often combine sites in Western Europe with sites in Central and Eastern Europe.
However, geography alone does not determine the final budget:
(1) Therapeutic area can be just as important as location
Based on our estimates, a Phase I cardiovascular trial in Western Europe may average approximately $1.66 million, compared with $4.10 million for a Phase I oncology trial. Differences in patient populations, procedures, monitoring requirements and study duration can all affect the budget.
(2) Modality introduces another major source of variation
A Phase II cell-therapy trial in Western Europe may cost approximately $37.23 million, while comparable small-molecule or antibody trials average around $14 million. Cell therapies often require complex manufacturing, specialized site capabilities, intensive patient monitoring and tightly coordinated logistics. Because manufacturing and delivery processes are less standardized than those used for conventional modalities, these trials cannot yet benefit from the same economies of scale.
The practical conclusion is that Europe should not be treated as a single low-cost region. The strongest savings usually come from selecting the right combination of countries and sites for the protocol, patient population and modality.
When sponsors move from a mostly US-based plan to a European site strategy, we have seen total projected costs come down by as much as 40% in Phase I. That is not something every program should expect, since the real number depends on the therapeutic area, how complex the protocol is, and which countries you choose, but it is a strong reason to consider the EU sites when planning a trial
European labor market rates for investigator fees, site coordinators, monitors, and data management staff are lower than US equivalents even in Western European countries. EU national health systems absorb standard-of-care procedures that US trial budgets often must cover directly.
Sertkaya and colleagues identified clinical procedures, administrative staff, and site monitoring as the three largest cost drivers across all trial phases in the US. Administrative staff alone accounted for 11-29% of per-study costs while site monitoring accounted for a further 9-14%.
All three are substantially cheaper in Europe. Investigator fees, site coordinator salaries, data management staff, and monitoring personnel are paid at European labor market rates, which sit below US equivalents even in high-cost Western European countries.
The second structural driver is healthcare system integration. In most European countries, national health systems cover standard-of-care procedures that run alongside a trial, so those costs sit outside the trial budget. In the United States, sponsors operate within a more fragmented payer and reimbursement environment, which makes separating trial-specific costs from standard-of-care more complex. That complexity often pushes the per-patient cost higher.
This timeline is a cost driver in its own right. Every month before the first patient in is a month of team salaries, IMP storage, site management fees, and delayed data. A 75-day difference in approval time between a slow-approving and a fast-approving member state represents meaningful budget exposure for an early-stage company.
The FDA reviews an IND application within 30 days, but that covers regulatory authorization only. Total time to first patient can reach several months. In the EU, regulatory approval runs approximately 35 to 110 calendar days depending on the member state.
The ACT EU report Monitoring the European clinical trials environment, covering January to March 2026, published by the European Medicines Agency and the European Commission recorded 208 new clinical trial applications submitted per month in CTIS during the first quarter of 2026, with a median of 118 days from submission to decision for new initial applications.
The key for a faster approval is avoiding mistakes during your application submission.
The largest budget surprises in clinical trials are not geography-specific but screen failure rates, protocol amendments, and country-specific activation costs. This applies regardless of whether a trial runs in the US or Europe, and all three are systematically underestimated in first-draft budgets. Additionally, most founders overestimate Phase III costs and underestimate Phase I costs.
(1) Screen failure rates
“Screen failures” refer to participants assessed for eligibility who do not meet the criteria to enroll. The rate varies substantially by indication. A Tufts CSDD study of 76 global Phase II and III trials found an overall average screen failure rate of 36.3%, with neuroscience trials topping the list at an average of 57%. In Alzheimer’s trials, rates above 70% have been documented. Every screen failure generates cost: the site visit, clinical assessments, and regulatory documentation, without contributing data to the study.
Well-designed inclusion and exclusion criteria, validated through site feasibility work before contracting, reduce this risk substantially. This applies regardless of jurisdiction.
(2) Protocol amendments
A protocol amendment is a formal, prospective revision to an approved clinical trial protocol that alters study design, procedures, participant safety, or scientific objectives in a substantial manner.
Getz and colleagues (2016 and 2022 follow-up study, Therapeutic Innovation and Regulatory Science) analyzed 836 protocols across Phase I through Phase IV and found that 57% of the protocols had at least one substantial amendment, and that nearly half of those amendments were considered avoidable.
The median direct cost to implement a substantial amendment was $141,000 for a Phase II protocol and $535,000 for a Phase III protocol. These costs were driven primarily by institutional review board (IRB) fees for amendment review and increased costs with existing vendor contracts. The most avoidable sources are design errors, eligibility criteria problems, and endpoints that cannot be consistently measured across sites. All are addressable with adequate upfront protocol planning.
(3) Country-specific regulatory and logistics costs
Every country in which sites operate requires its own regulatory authorization. In the US, this is managed through a single FDA IND, with site-level IRB approvals. In the EU, CTIS coordinates the assessment through a single Reporting Member State, chosen by the sponsor, which leads the Part I scientific and technical review. Once the Reporting Member State completes its assessment, unless there are disagreements over patient safety compared with standard clinical practice, the other Member States will follow. They retain authority only over Part II, the country-specific requirements covering ethics, data protection, and local site matters, so participating Member States may still authorize and activate a trial at different times.
For sponsors running their first EU trial, the per-country variation in activation timelines is one of the most significant and least anticipated sources of budget and schedule variance. A five-country EU trial with staggered country activation timelines can mean the first patient differs by several months between the first and last country to activate. That gap carries direct costs. Project management effort, site management fees, IMP logistics and storage, and allocated monitoring resources accumulate at activated sites while other Member States are still working through their national authorization processes
About the Author
PD Dr. Ghazaleh Gouya-Lechner is the founder of Gouya Insights and a cardiologist with over 20 years of hands-on clinical practice. She has worked across clinical development, regulatory strategy, and pharmacovigilance for both pharmaceutical and medical device companies. In 2017 she founded Gouya Insights, a CRO supporting early-stage biotech and medtech companies through clinical trials and drug development.
Frequently asked questions
Is it cheaper to run a clinical trial in Europe than in the US?
Yes. Per-site costs in Central Europe average approximately 50 percent of North American equivalents, based on Qiao et al. (2019). In Gouya Insights’ client experience, cost reductions when moving from a US plan to a European site strategy have reached as much as 40 percent, depending on therapeutic area, protocol complexity, and country mix.
How much does it costs to run a clinical trial in Europe?
Costs vary by phase, country, and modality. Median single-country estimates run from 1.54 million dollars for a Phase I trial in Central and Eastern Europe to 21.15 million dollars for a Phase III trial in the same region, compared with 4.25 million and 50.40 million dollars respectively in the United States. Therapeutic area and modality shift these figures substantially, so the specific protocol and site mix matter more than the region alone.
How long does it take to start a clinical trial in Europe?
Regarding regulatory processes, the EU-wide average approval timeline under CTIS is approximately 110 days. Fast-approving member states including Austria, Belgium, and Germany target approximately 35 days for mono-national applications. That timeline is conditional on submitting a complete, well-prepared dossier.
For study set-up, a sponsor should calculate a minimum of 6 months for a multi-center study.
Which European country is fastest for clinical trial approval?
Austria, Belgium, and Germany have the most documented commitment to 35-day review timelines for mono-national applications. Austria is a practical choice for first-in-human studies given the accessibility of pre-submission dialogue with BASG and the experience of its ethics committees with early-phase protocols.
References
1. Sertkaya A, Wong HH, Jessup A, Beleche T. “Key cost drivers of pharmaceutical clinical trials in the United States.” Clinical Trials. 2016;13(2):117-126. https://journals.sagepub.com/doi/10.1177/1740774515625964
2. Moore TJ, Zhang H, Anderson G, Alexander GC. “Estimated costs of pivotal trials for novel therapeutic agents approved by the US Food and Drug Administration, 2015-2016.” JAMA Internal Medicine. 2018;178(11):1451-1457. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2702287
3. Qiao Y, Alexander GC, Moore TJ. “Globalization of clinical trials: Variation in estimated regional costs of pivotal trials, 2015-2016.” Clinical Trials. 2019;16(3):329-333. https://journals.sagepub.com/doi/abs/10.1177/1740774519839391
4. Moore TJ, Heyward J, Anderson G, Alexander GC. “Estimated costs of pivotal trials for US FDA-approved cancer drugs, 2015-2017.” BMJ Open. 2020;10(6):e038863. https://pmc.ncbi.nlm.nih.gov/articles/PMC7295430/
5. US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. “Drug Development.” 2024. https://aspe.hhs.gov/reports/drug-development
6. Speich B, von Niederhäusern B, Schur N, Hemkens LG, Fürst T, Bhatnagar N, et al. “Systematic review on costs and resource use of randomised clinical trials shows a lack of transparent and comprehensive data.” Journal of Clinical Epidemiology. 2018;96:1-11. https://doi.org/10.1016/j.jclinepi.2017.12.018
7. Getz KA, Stergiopoulos S, Short M, Surgeon L, Krauss R, Pretorius S, et al. “The impact of protocol amendments on clinical trial performance and cost.” Therapeutic Innovation & Regulatory Science. 2016;50(4):436-441. https://link.springer.com/article/10.1177/2168479016632271
8. Getz KA, et al., Tufts Center for the Study of Drug Development. “New benchmarks on protocol amendment practices, trends and their impact on clinical trial performance.” Therapeutic Innovation & Regulatory Science. 2024. https://link.springer.com/article/10.1007/s43441-024-00622-9
9. Tufts Center for the Study of Drug Development. “Screen failure and dropout rates in Phase II and III clinical trials.” 2020. https://csdd.tufts.edu/
10. European Medicines Agency. “Clinical Trials Information System (CTIS).” 2025. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-ctis
11. European Medicines Agency. “Clinical Trials Regulation (EU) No 536/2014.” 2022. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
12. Frontier Economics / EFPIA. “The economic impact of industry clinical trials across Europe.” February 2026. https://efpia.eu/media/zdzg0bey/the-economic-impact-of-industry-clinical-trials-across-europe.pdf
Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials
