Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review
Abstract
Background: A significant barrier to conducting clinical trials is their high cost, which is driven primarily by the time and resources required to activate trials and reach accrual targets. The high cost of running trials has a substantial impact on their long-term feasibility and the type of clinical research undertaken. Methods: A scoping review of the empirical literature on the costs associated with conducting clinical trials was undertaken for the years 2001–2015. Five reference databases were consulted to elicit how trials costs are presented in the literature. A review instrument was developed to extract the content of in-scope papers. Findings were characterized by date and place of publication, clinical disease area, and network/cooperative group designation, when specified. Costs were captured and grouped by patient accrual and management, infrastructure, and the opportunity costs associated with industry funding for trials research. Cost impacts on translational research and health systems were also captured, as were recommendations to reduce trial expenditures. Since articles often cited multiple costs, multiple cost coding was used during data extraction to capture the range and frequency of costs. Results: A total of 288 empirical articles were included. The distribution of reported costs was: patient management and accrual costs (132 articles), infrastructure costs (118 articles) and the opportunity costs of industry sponsorship (72 articles). 221 articles reported on the impact of undertaking costly trials on translational research and health systems; of these, the most frequently reported consequences were to research integrity (52% of articles), research capacity (36% of articles) and running low-value trials (34% of articles). 254 articles provided recommendations to reduce trial costs; of these, the most frequently reported recommendations related to improvements in: operational efficiencies (33% of articles); patient accrual (24% of articles); funding for trials and transparency in trials reporting (18% of articles, each). Conclusion: Key findings from the review are: 1) delayed trial activation has costs to budgets and research; 2) poor accrual leads to low-value trials and wasted resources; 3) the pharmaceutical industry can be a pragmatic, if problematic, partner in clinical research; 4) organizational know-how and successful research collaboration are benefits of network/cooperative groups; and 5) there are spillover benefits of clinical trials to healthcare systems, including better health outcomes, enhanced research capacity, and drug cost avoidance. There is a need for more economic evaluations of the benefits of clinical research, such as health system use (or avoidance) and health outcomes in cities and health authorities with institutions that conduct clinical research, to demonstrate the affordability of clinical trials, despite their high cost.
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The collection of real-world data during clinical trials imposes high demands on researchers due to the need for data integration, structuring, access-protected viewing, exploration, and analysis, especially if derived from various sources.
“The collection of real-world data during clinical trials imposes high demands on researchers due to the need for data integration, structuring, access-protected viewing, exploration, and analysis, especially if derived from various sources (eg, wearables, questionnaires, and symptom/event logs). 1”
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“…mechanistic research and the testing of combined approaches (such as drug and exercise interventions), large-scale efficacy and cost-effectiveness trials are likely to be increasingly supported by the pharmaceutical industry owing to the commercial potential of these interventions [212].”
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- Authors
- Bentley, C., Cressman, S., van der Hoek, K., Arts, K., Dancey, J., & Peacock, S.
- Affiliations
- BC Cancer Agency (CA)
- Department of Cancer Control Research, BC Cancer, Vancouver, BC, Canada
- Ontario Institute for Cancer Research (CA)
- Corresponding author
- Bentley, Colene
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2019-01-10
- Volume
- 16
- Issue
- 2
- Pages
- 183-193
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- OpenAlex
- W2909678312
- Cited by
- 104
- References
- 73
- Citations by year
- 2026: 14 · 2025: 19 · 2024: 22 · 2023: 19 · 2022: 7 · 2021: 13 · 2020: 7 · 2019: 3
- FWCI
- 1.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Canadian Cancer Society Research Institute (2015-703549)
- Ontario Institute for Cancer Research (3CTN-ARCC-BCCA)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- clinical trial costs, clinical trial networks, cooperative groups, patient accrual, opportunity cost, industry funding, research integrity, research capacity, translational research, health care system, cost reduction, trial funding, research collaboration, health outcomes, operational efficiency
- MeSH terms
- Clinical Trials as Topic, Cooperative Behavior, Delivery of Health Care, Drug Industry, Humans, Time Factors, Models, Economic, Biomedical Research, Translational Research, Biomedical
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