Commercializing Clinical Trials — Risks and Benefits of the CRO Boom
Abstract
In a trend that has received surprisingly little attention, contract research organizations (CROs) have gradually taken over much of academia's traditional role in drug development over the past decade. They've been able to do so by offering greater speed and efficiency in conducting clinical trials than academic groups can, but questions have been raised about their qualifications, ethics, accountability, and degree of independence from their pharmaceutical-industry clients.Annual CRO-industry revenues have increased from about $7 billion in 2001 to an estimated $17.8 billion today; of more than 1000 CROs in operation, the four largest — Quintiles, Covance, Pharmaceutical Product Development . . .
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The system would reduce the cost in clinical trials by decreasing the amount currently spent on confirmation by a third party such as a contract research organization.
“the system would reduce the cost in clinical trials by decreasing the amount currently spent on confirmation by a third party such as a contract research organization [41]”
From Tamper-Resistant Mobile Health Using Blockchain Technology. (2017) · cites this paper as [41]
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Ethical and Scientific Implications of the Globalization of Clinical Research
Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., & Schulman, K. A. (2009) · New England Journal of Medicine · doi:10.1056/nejmsb0803929 · Cited by 710 · see citing works
Tamper-Resistant Mobile Health Using Blockchain Technology.
Ichikawa, D., Kashiyama, M., & Ueno, T. (2017) · JMIR mHealth and uHealth · doi:10.2196/mhealth.7938 · Cited by 298 · see citing works
“…(1) the system would reduce the cost in clinical trials by decreasing the amount currently spent on confirmation by a third party such as a contract research organization [41]; and (2) it could reduce the possibility of human error because the system could minimize human involvement with the data.”
- Authors
- Shuchman, M.
- Corresponding author
- Shuchman, Miriam
- ORCID
- Shuchman, Miriam
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2007-10-04
- Volume
- 357
- Issue
- 14
- Pages
- 1365-1368
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2089231915
- Cited by
- 124
- References
- 0
- Citations by year
- 2026: 1 · 2024: 2 · 2023: 1 · 2022: 2 · 2021: 1 · 2020: 3 · 2019: 3 · 2017: 4 · 2016: 4 · 2015: 7 · 2014: 16 · 2013: 12 · 2012: 10
- FWCI
- 14.05
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- contract research organizations, clinical trials, drug development, pharmaceutical industry, research ethics, conflicts of interest
- MeSH terms
- Academic Medical Centers, Clinical Trials as Topic, Commerce, Contract Services, Drug Industry, Humans, United States
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