Key cost drivers of pharmaceutical clinical trials in the United States
Abstract
Background: The increasing cost of clinical research has significant implications for public health, as it affects drug companies’ willingness to undertake clinical trials, which in turn limits patient access to novel treatments. Thus, gaining a better understanding of the key cost drivers of clinical research in the United States is important. Purpose: The study which is based on a report prepared by Eastern Research Group, Inc., for the US Department of Health and Human Services, examined different factors, such as therapeutic area, patient recruitment, administrative staff, and clinical procedure expenditures, and their contribution to pharmaceutical clinical trial costs in the United States by clinical trial phase. Methods: The study used aggregate data from three proprietary databases on clinical trial costs provided by Medidata Solutions. We evaluated per-study costs across therapeutic areas by aggregating detailed (per patient and per site) cost information. We also compared average expenditures on cost drivers with the use of weighted mean and standard deviation statistics. Results: Therapeutic area was an important determinant of clinical trial costs by phase. The average cost of a Phase 1 study conducted at a US site ranged from US$1.4 million (pain and anesthesia) to US$6.6 million (immunomodulation), including estimated site overhead and monitoring costs of the sponsoring organization. A Phase 2 study cost from US$7.0 million (cardiovascular) to US$19.6 million (hematology), whereas a Phase 3 study cost ranged from US$11.5 million (dermatology) to US$52.9 (pain and anesthesia) on average. Across all study phases and excluding estimated site overhead costs and costs for sponsors to monitor the study, the top three cost drivers of clinical trial expenditures were clinical procedure costs (15%–22% of total), administrative staff costs (11%–29% of total), and site monitoring costs (9%–14% of total). Limitations: The data were from 2004 through 2012 and were not adjusted for inflation. Additionally, the databases used represented a convenience, that is, non-probability, sample and did not allow for statistically valid estimates of cost drivers. Finally, the data were from trials funded by the global pharmaceutical and biotechnology industry only. Hence, our study findings are limited to that segment. Conclusion: Therapeutic area being studied as well as number and types of clinical procedures involved were the key drivers of direct costs in Phase 1 through Phase 3 studies. Research shows that strategies exist for reducing the price tag of some of these major direct cost components. Therefore, to increase clinical trial efficiency and reduce costs, gaining a better understanding of the key direct cost drivers is an important step.
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Planning and executing a high-quality clinical trial is time consuming and financially very costly.
“Unfortunately, planning and executing a high-quality clinical trial is not only time consuming (usually taking many years to recruit enough participants and follow them in time) but also financially very costly 30,31 .”
From Multimodal biomedical AI (2022) · cites this paper as [31]
Results of animal experiments cannot directly verify the toxicity and side effects of drugs in humans due to species differences.
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From Tumor-on-a-chip: from bioinspired design to biomedical application (2021) · cites this paper as [12]
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“The estimated cost ranges from 161 million to 2 billion dollars and is likely even higher today (Sertkaya et al. 2016).”
- Authors
- Sertkaya, A., Wong, H.-H., Jessup, A., & Beleche, T.
- Affiliations
- Eastern Research Group (United States) (US)
- United States Department of Health and Human Services (US)
- United States Food and Drug Administration (US)
- Corresponding author
- Sertkaya, Aylin
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2016-02-08
- Volume
- 13
- Issue
- 2
- Pages
- 117-126
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- OpenAlex
- W2263715254
- Cited by
- 401
- References
- 17
- Citations by year
- 2026: 24 · 2025: 44 · 2024: 39 · 2023: 56 · 2022: 42 · 2021: 58 · 2020: 50 · 2019: 38 · 2018: 24 · 2017: 21 · 2016: 5
- FWCI
- 56.99
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Health and Human Services
- Centers for Disease Control and Prevention (HHSP23320095634WC)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Keywords
- clinical trial costs, cost drivers, pharmaceutical industry, therapeutic areas, clinical trial phases, patient recruitment, drug development costs, cost reduction strategies, clinical trial efficiency, Medicare Part B, Medicare Advantage
- MeSH terms
- Pharmaceutical Research, Clinical Trials as Topic, Costs and Cost Analysis, United States, Databases, Factual
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