Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

PLOS ONE, Dec 2019

Background Mapping the international landscape of clinical trials may inform global health research governance, 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 industry- and non-industry–sponsored clinical trials and its evolution over time. Methods 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. Results 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 non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored 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.

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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 - 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)


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Ignacio Atal, Ludovic Trinquart, Raphaël Porcher, Philippe Ravaud. Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials, PLOS ONE, 2015, Volume 10, Issue 12, DOI: 10.1371/journal.pone.0145122