Globalization of clinical trials: ethical and regulatory implications
DOI:
https://doi.org/10.18203/2349-3259.ijct20160472Keywords:
Clinical Trials, Globalization, Emerging countries, Ethics in research, Regulatory agency, DrugsAbstract
The globalization of clinical research is a relatively recent phenomenon, in which many of these studies are taking place on a global scale, with a significant increase of clinical trials in developing countries. The largest clinical trials average annual growth from 2005–2012 occurred in Asian (30%), and Latin American/Caribbean (12%) regions; other geographic regions had growth rates less than the world average (8%). The largest average annual growth occurred in lower-middle income (33%) and low-income (21%) regions. Emerging economies from low-middle income countries (Iran, China, Egypt) had the largest country-specific growth; other countries included South Korea, Japan, India, Brazil, and Turkey. With the globalization of clinical trials, it becomes necessary to strengthen legal and ethical guidelines for guaranteeing the research participants’ integrity. Some observers noted, more than a decade ago, that studies were being run in developing countries without concerns regarding adherence to the international ethical principles. The process of globalization of clinical trials, therefore, can be advantageous because, for example, it gives to access to new treatments to participants; however, it requires discussion and the monitoring of ethical questions related mainly to ensuring the integrity, welfare and safety of the research participant; to the frames of reference of bioethics, such as autonomy, nonmaleficence, beneficence, justice and fairness.References
Pieroni JP, Gomes RP, Pimentel VP e Landim AB. Ensaios clínicos no Brasil: competitividade internacional e desafios. Complexo Industrial da Saúde. BNDES Setorial. 2012;36:45-84.
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA. Ethical and scientific implications of the globalization of clinical research. The New England J Med. 2009;360(8):816-23.
Lang T, Siribaddana S. Clinical trials have gone global: is this a good thing? PLoS Medicine. 2012;9(6):1-5.
Virk KP. Addressing issues affecting clinical trials in Brazil. Clin Res Regulat Aff. 2010;27(2):1-8.
Organização Panamericana da Saúde. Organização Mundial da Saúde. Rede Panamericana para Harmonização da Regulamentação Farmacêutica Boas Práticas Clínicas: documento das Américas. 2005.
European Medicines Agency (EMA). Annual report of the Good Clinical Practices inspectors working group 2012.
Health Canada. Summary report of inspections of clinical trials conducted from April 2004 to March 2011 [cited 8th November 2013]. Available at http://www.hc-sc.gc.ca/dhp-mps/compli conform/clini-pract-prat/report-rapport/2004-2011-eng.php#a53. Accessed on 02 May 2014.
Brasil. Agência Nacional de Vigilância Sanitária. Ministério da Saúde. Inspeções em Boas Práticas Clínicas. Pasta Pública. 2014.
Annas GJ. Globalized clinical trials and informed consent. The New England J Med. 2009;360:2050-53.
Thiers FA; Sinskey AJ; Berndt ER. Trends in the globalization of clinical trials. Nature Rev Drug Discov. 2008;7:13-4.
Drain PK, Robine M, Holmes KK, Bassett IV. Global migration of clinical trials in the era of trial registration. Nat Rev Drug Discov. 2014;13(3):166-7.
Berndt ER, Cockburn I, Thiers FA. The globalization of clinical trials for new medicines into emerging economies: where are they going and why?" UNU-MERIT Conference, micro evidence on innovation in developing countries, Maastricht, the Netherlands. 2007.
Jessop N. European regulators struggle with globalisation of clinical trials: the globalisation of clinical trials is putting pressure on the European Medicines Agency. Pharm Tech Europe. 2012;24(6):1-5.
Novaes MRG, Quezada FLA. Ética Y Farmacia. Una Perspectiva Latinoamericana. Ética y ensayos clínicos: preguntas y dilemas. Centro Interdisciplinario de Estudios en Bioetica - Universidad de Chile, Programa de Bioetica - OPS/OMS. Monografias de Acta Bioethica, Nᵒ 2. 2009.
Food and Drug Administration – FDA. Inspections, compliance, enforcement, and criminal investigations. Clinical investigators - disqualification proceedings. Available at http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm. Accessed on 02 May 2014.
Sepúlveda AQ. Perspectivas éticas de la publicación Biomédica. In: Novaes, et all (editores). Monografías de Acta Bioethica. Ética y Farmacia. Una Perspectiva Latinoamericana. Centro Interdisciplinario de Estudios en Bioética- Universidad de Chile–OPAS/OMS: Nᵒ2, OPAS/OMS; 2009:301-310.
Marcos JF; Bisson, MP. Ética e industria farmacéutica: patentes, publicidad y salud. In: Novaes, et all (editors). Monografías de Acta Bioethica. Ética y Farmacia. Una Perspectiva Latinoamericana. Centro Interdisciplinario de Estudios en Bioética - Universidad de Chile-OPAS/OMS: Nᵒ2, OPAS/OMS; 2009:219-241.
Rochon PA, Sekeres M, Hoey J, Lexchin J, Ferris LE, Moher D et al. Investigator experiences with financial conflicts of interest in clinical trials. Trials. 2011;12(9):1-9.
Hanauer SB. Outsourcing clinical trials. Nature reviews / gastroenterology and hepatology. 2009;6:191.
Allison M. Reinventing clinical trials. Nature biotechnology. 2012;30(1):41-9.
Binkowitz B, Ibia E. Multiregional clinical trials: an introduction from an industry perspective. Drug Inform J. 2011;45:569.
Hughes B. Evolving R&D for emerging markets. Nature Rev Drug Discov. 2010;09:417-20.
Silva RE, Novaes MRC, Pastor EM, Barragan E, Amato AA. Trends in research involving human beings in Brazil. Rev Panam Salud Publica. 2015;37(2):118-24.
Associação da Indústria Farmacêutica de Pesquisa – Interfarma. Opportunities for Brazyl and for Brazilians. Innovation and Clinical Research in Brazil. Editions Specials Health, volume II, Outubro; 2010.
Brasil. Conselho Nacional de Saúde. Ministério da Saúde Resolução 466/12. Diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. Brasília: Ministério da Saúde; 2012.
Brasil. Conselho Nacional de Saúde. Ministério da Saúde Resolução 251/1997. Diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos para a área temática de pesquisa com novos fármacos, medicamentos, vacinas e testes diagnósticos. Brasília: Ministério da Saúde; 1997.
Novaes MRG, Novaes LCG, Guilhem D, Stepke FL, Silveira CCC, Komatsu RS et al. Actitudes Éticas de los estudiantes y egresados en carrera de medicina con metodologias activas. Revista Brasileira de Edu Méd. 2010;34(1):43-56.
