Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials
December
Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials
Ignacio Atal 0 1
Ludovic Trinquart 0 1
Raphaël Porcher 0 1
Philippe Ravaud 0 1
0 1 Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Paris, France, 2 INSERM U1153, Paris, France, 3 Columbia University, Mailman School of Public Health, Epidemiology Department , New York , New York, United States of America, 4 Université Paris Descartes , Paris , France
1 Editor: Joel Lexchin, York University , CANADA
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OPEN ACCESS
Data Availability Statement: All relevant data are
within the paper and its Supporting Information files.
Funding: This work was supported by an academic
grant (DEQ20101221475) for the programme Equipe
Espoirs de la Recherche, from the Fondation pour la
Recherche Médicale, France. The funders had no
role in study design, data collection and analysis,
decision to publish, or preparation of the manuscript.
Competing Interests: The authors have declared
that no competing interests exist.
Background
Mapping the international landscape of clinical trials may inform global health research gov
ernance, but no large-scale data are available. Industry or non-industry sponsorship may
have a major influence in this mapping. We aimed to map the global landscape of
industryand non-industry–sponsored clinical trials and its evolution over time.
Results
We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO
International Clinical Trials Registry Platform (ICTRP). We mapped single-country and
international trials by World Bank's income groups and by sponsorship (industry- vs. non-
industry), including its evolution over time from 2006 to 2012. We identified clusters of countries
that collaborated significantly more than expected in industry- and non-industry–sponsored
international trials.
119,679 clinical trials conducted in 177 countries were analysed. The median number of
trials per million inhabitants in high-income countries was 100 times that in low-income
countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million
inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in
ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and
nonindustry–sponsored trials, 30.3% and 3.2% were international, respectively. In the
industrysponsored network of collaboration, Eastern European and South American countries
collaborated more than expected; in the non-industry–sponsored network, collaboration
among Scandinavian countries was overrepresented. Industry-sponsored international
trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%)
as compared with non-industry–sponsored trials (from 42.4% to 37.2%).
Conclusions
Based on trials registered in the WHO ICTRP we documented a substantial gap between
the globalization of industry- and non-industry–sponsored clinical research. Only 3% of
academic trials but 30% of industry trials are international. The latter appeared to be conducted
in preferentially selected countries.
Introduction
Clinical trials are fundamental in advancing knowledge and improving health care globally.
[
1,2
] By evaluating health interventions, clinical trials bring evidence about pharmacological
and non-pharmacological therapies. International collaboration in clinical trials offers
numerous advantages for the generation and interpretation of evidence.[
3–6
] Apart from accelerating
the accrual of patients, especially for uncommon diseases, an important advantage in operating
trials across countries is to increase the applicability of research findings. International
collaboration in health research may also play an important role in reducing waste in health research.
[
7
] Moreover, international clinical trials may strengthen health care systems in emerging
economies because externally sponsored trials may increase the research capacity of sites in
developing countries.[
2,3
]
As recently stated in Science, "the issue of knowing what research is currently being
undertaken—where, by whom, and which organizations are supporting it—is a black hole in the
public health landscape".[
8
] The international landscape of health research should be mapped to
inform global governance and policy development.[
9
] In the last two decades, the number of
clinical trials has expanded worldwide, and developing countries are increasingly involved,
with a migration of trials from North America and Europe to Asia and Latin America.[
10–12
]
Unravelling the forces that shape the research agenda may help steer it toward the most
relevant health issues, to address the disparity between the local health burden and the production
of health knowledge through clinical trials.[
13,14
]
A specific area of concern is the extent to which the clinical research landscape is dominated
by industry sponsors.[
15
] In particular, international c (...truncated)