Clinical trials form the backbone of drug development, enabling pharmaceutical companies to determine the safety and efficacy of novel therapies. But the price tag of bringing a drug from the discovery stage to the market has seen a dramatic and continuous rise. This burgeoning cost of clinical research has significant implications for public health, because it makes drug companies diffident to newer clinical trials thereby limiting patient access to much needed novel treatments. The non-profit Institute for Safe Medication Practices (ISMP) analyzed data from 225 individual trials for 101 new drugs approved from 2015 to 2017 and concluded the median cost of each was $19 million (with a range of $12 million to $33 million)1. The key factors behind this divergence were respective therapeutic areas and the mode of treatment. For example, trials involving eye drops, skin creams and other topical infusions were less expensive as opposed to other complex studies such as intensive treatments for oncology or other life-threatening ailments such as heart disease. The lowest estimated trial cost was $2 million for a four-patient trial for a rare metabolic disorder, whereas a large study of a heart-failure drug cost $347 million2. Costs tended to be higher when a trial lasted longer or enrolled more patients or when comparing a new drug to an existing standard over a placebo.
Over the past decade, clinical trial expenses have surged due to increasing regulatory complexity, globalization of trial sites, and the development of advanced therapies such as biologics and cell and gene therapies. For instance, between 2013 and 2023, the average cost per patient in a Phase III trial increased by nearly 50%, with oncology trials often exceeding $100,000 per patient3. Cell and gene therapy trials oncology and rare genetic disorders can easily cost over $1 million per patient with several of the approved gene therapies priced anywhere from $2 million to $4 million4. Hence, whether you are a biotech startup or a large pharmaceutical company, managing clinical trials requires not only scientific rigor but also financial foresight, fiscal prudence and operational efficiency. A well-structured clinical development plan, early investment in clinical trial consulting, and strategic partnerships with experienced CROs can make a significant difference.
The number of patients enrolled is one of the largest cost drivers in any clinical trial. Based on the ISMP study, trials with fewer than 100 patients had an average cost of just $6 million, while the trials with more than 1,000 patients had an average cost of $77 million1. In addition, the indication under study also determines overall expenses because recruiting participants takes time, plus the costs per patient, ranging from medical procedures to compensation and travel, can all add up quickly. For example, enrolling 1,000 patients in a cardiovascular trial may cost several millions of dollars just for recruitment-related expenses.
The geographic footprint of a clinical trial significantly affects its cost. Phase 3 trials often involve multiple sites across the globe due to the large number of patients and also patient diversity to be met as a critical component of the trials. Multi-country trials also require compliance with each nation’s regulatory bodies, translation of materials, local ethics committee approvals, and logistical coordination. Each additional clinical site introduces new layers of project management, site monitoring, and data management.
The therapeutic area has the most direct impact on cost. Oncology, neurology, cardiovascular and rare diseases tend to be the most expensive due to complex endpoints, long follow-up periods, and intensive monitoring. For example, pivotal cardiovascular drug trials have a mean cost of $157 million, versus just $21 million for pivotal trials in endocrine and metabolic diseases6. The endpoints of the trial also affect the overall costs. An endpoint that measures a clinically meaningful outcome such as the ability of a drug to prevent a heart attack, tends to have a much higher median cost around $65 million than when measuring a surrogate outcome such as high serum cholesterol (median $24 million)6. The type of drug being tested, small molecules, biologics, or gene therapy, also affects cost due to specialized handling, chemistry and manufacturing controls (CMC) and safety monitoring.
Protocol complexity, particularly the number and frequency of tests and procedures, can rapidly escalate costs. Trials may include multiple lab tests, imaging, biopsies, ECGs, and frequent blood draws. Each added procedure contributes to patient burden and requires extensive coordination. Several of these tests also require hospital and ICU stays which build up the costs.
Given the increasing complexity of clinical trials, most sponsors partner with Contract Research Organizations (CROs) to manage logistics, regulatory submissions, data collection, site monitoring, and quality assurance. A full service CRO offers end-to-end solutions, from feasibility to final report, thereby helping sponsors navigate regulatory requirements and manage timelines effectively. Trial management outsourcing to CROs has become an integral part of all clinical trials with several specialized reputed CROs such as Palleos offering efficient end-to-end services 7.
CROs calculate their budgets based on the scope of work, projected trial duration, therapeutic area, and country-specific cost factors. Budget items typically include project management, monitoring visits, data management, and safety reporting. The ultimate costs are always determined by the scope and complexity of the trial. Some large multinational CROs may charge a premium due to their brand and extensive infrastructure. Smaller, regionally focused CROs often offer more flexibility, better communication, and lower overhead, resulting in cost-effective execution.
Palleos is a CRO in Germany that provides full-service clinical trial support across Central and Eastern Europe8. As a mid-sized, independent company, Palleos is known for hands-on management, transparent pricing, and deep therapeutic expertise. Our flexible and responsive approach makes us an ideal partner for cost-conscious, high-quality clinical development. We have been conducting trials for over 20 years in approximately 29 therapeutic areas for a wide variety of clients from small mid-size biotech to big pharma.
As clinical trials grow increasingly complex and expensive, it is more critical than ever to choose partners who offer not just expertise, but also financial transparency, fiscal prudence and operational flexibility. The escalating costs, from patient recruitment to data analysis, require a strategic clinical development plan and experienced partners who can help control expenses without compromising on quality.
This is where Palleos CRO stands out. As a full service CRO based in Germany, Palleos offers a comprehensive suite of services with clear budgets, no surprise costs, and reasonable expenses, making them a trusted partner for managing clinical trials of any scale. We also take utmost care to prevent surprise costs and unforeseen escalations as much as possible.
Whether you are an early-stage biotech or a pharma company expanding in Europe, Palleos can support your needs with customized clinical trial consulting, dedicated project managers, and a proven track record of success.
Explore Palleos’ full range of services, including site monitoring, regulatory strategy, project management, and more. Their commitment to transparency, quality, and cost-efficiency makes them an ideal CRO partner for your next clinical development program.
Visit palleos.com/ to learn more or schedule a consultation with the expert team today.
DiMasi, J. A., et al. (2016). “Innovation in the pharmaceutical industry: New estimates of R&D costs.” J Health Econ 47: 20-33.
Moore, T. J., et al. (2018). “Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016.” JAMA Intern Med 178(11): 1451-1457.
Sertkaya, A., et al. (2016). “Key cost drivers of pharmaceutical clinical trials in the United States.” Clin Trials 13(2): 117-126.
Mulcahy, A., et al. (2025). “Use of Clinical Trial Characteristics to Estimate Costs of New Drug Development.” JAMA Netw Open 8(1): e2453275.
Bentley, C., et al. (2019). “Conducting clinical trials-costs, impacts, and the value of clinical trials networks: A scoping review.” Clin Trials 16(2): 183-193.
Doxzen, K. W., et al. (2024). “The translational gap for gene therapies in low- and middle-income countries.” Sci Transl Med 16(746): eadn1902.
