Globalization and Clinical Research in Latin America
The globalization of clinical research lagged behind the globalization of other sectors of the economy and received a substantial impulse after the adoption of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the approval
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Globalization and Clinical Research in Latin America Nuria Homedes and Antonio Ugalde
The globalization of pharmaceutical clinical trials lags behind that of other industries because, until relatively recently, low- and middle-income countries did not have the safeguards the industry needed. Traditionally, clinical trials took place in high-income countries (United States, Europe, Japan and Australia) and the pharmaceutical industry, before gathering clinical trial data in other countries, had to ensure that the regulatory agencies of the countries where 80 % of the pharmaceuticals are consumed (United States, Europe and Japan) would accept the trial results from low- and middle-income countries (Eastern Europe, Latin America, Asia) included in the applications for market authorization. Another requirement was the existence of adequate systems to ensure the integrity of the research and the protection of intellectual property. The approval of the guidelines from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH GCP) in 1996 (ICH 1996) and the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (WTO 1994) (Virk 2009; Glickman et al. 2009) satisfied the needs of research sponsors. Clinical trials now take place anywhere in the world, and it is expected that the number of trials conducted in low- and middle-income countries will increase significantly in the near future. This chapter will describe the need for globalized recruitment, the development of clinical trials in Latin America and the factors contributing to the expansion of clinical trials in the region, and finally the consequences that this process may have for the countries and for the participants will be discussed.
N. Homedes (*) School of Public Health, Division of Management Policy and Community Health, University of Texas Houston Health Science Center, El Paso, TX, USA e-mail: [email protected] A. Ugalde Department of Sociology, University of Texas, Austin, TX, USA N. Homedes and A. Ugalde (eds.), Clinical Trials in Latin America: Where Ethics and Business Clash, Research Ethics Forum 2, DOI 10.1007/978-3-319-01363-3_3, © Springer International Publishing Switzerland 2014
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N. Homedes and A. Ugalde
The Need and Extend of Globalized Recruitment
The pharmaceutical companies like other businesses move some of their operations to other countries to reduce costs, but more importantly, the pharmaceutical industry needs to recruit trial participants in low- and middle-income countries because it is unable to enroll sufficient participants in high-income countries. The need for trial participants has escalated as a result of the increase in the number and sample size of the research protocols. Between 1981 and 1984, the pivotal trials included in the applications for market authorization included an average of 1,321 participants, while in 1994–1995 the average sample size was 4,237 (Department of Health and Human Services 2000). Karlber
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