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First book to give an overview of the outsourcing of clinical trials in Latin America
Raises questions about the quality of data obtained from the trials and the violation of human rights during their implementation
Addresses the economic reasons as to why clinical trials happen more frequently in certain parts of the world
The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.
Content Level »Research
Keywords »Argentina bioethics - Clinical Trials - Ethics and business - Latin America - Outsourcing clinical trials - clinical trials Latin America
Introduction; Núria Homedes and Antonio Ugalde.- A Review and Critique of International Ethical Principles;Núria Homedes and Antonio Ugalde.- Globalization and Clinical Research in Latin America; Núria Homedes and Antonio Ugalde.- The Regulatory Framework and Case Studies from Argentina; Antonio Ugalde and Núria Homedes .- Politics and Clinical Trials in the Province of Cordoba; Antonio Ugalde and Núria Homedes.- Brazil: The System for the Protection of Voluntary Participants in Research; Corina Bontempo D de Freitas, William Saad Hossne and Susie Dutra.- Progress and Challenges of Clinical Research with New Medications in Brazil;Corina Bontempo D de Freitas and Bruno Schlemper Junior.- A Small Country for Big Pharma: Costa Rica; Antonio Ugalde and Núria Homedes.- Cervical Cancer and the Development of HPV Vaccines in Guanacaste, Costa Rica; Núria Homedes and Antonio Ugalde.- Ethical Guidelines for Clinical Trials in Mexico: Theory and Practice; Emma Verástegui and Edith Valdés-Martínez.- Who Decides? Informed Consent among Cancer Patients in México; Alonso Cerdán, Alejandro González and Emma Verástegui.- A View from Inside: Regulation and Ethical Conflicts in Peru;
Gabriela Minaya Martínez, Susi Olave Quispe and Duilio Fuentes Delgado.- Conclusion; Antonio Ugalde and Núria Homedes.