Resumen

SANABRIA-ROJAS, Hernán A. Clinical trials in neglected infectious diseases in the context of globalization: an ethical and human rights approach. Acta méd. peruana [online]. 2015, vol.32, n.4, pp.235-240. ISSN 1728-5917.

Introduction. Recent epidemics of neglected infectious diseases (NTD) bring up some existing problems such as underdevelopment of new drugs by the pharmaceutical industry and national states. Little or no supply of medicines against such diseases is thus generated. Within the process of globalization, the pharmaceutical industry has been developing a multinational strategy of developing new drugs according to their interest in developing countries. Since the issue has repercussions in the economic, ethical, political and human rights aspects, it seeks to expand knowledge on the process of implementation of clinical trials (CT) on NTD in Peru. Materials and Method. EC authorized 1493 were revised in Peru between July 1995 and June 2015. Each of the titles to the authorized EID was verified by the project code contained on the website of the National Institute of Health. Results. In the twenty years evaluated, they were authorized 17 CT and two others were in the process of authorization. The findings represented 1.3% of total authorized protocols; i.e., 0.95 clinical trials on clinical trials per year of study. The EID/noEID reason was 1/78. The CT on EID performed in Peru accounted for cysticercosis, leishmaniasis, strongyloidiasis, dengue, yellow fever and geoheliminthiasis, among other parasites such as cryptosporidiosis. Conclusions. Between July 1995 and June 2015, in Peru there was a small number of clinical trials on new drugs for neglected infectious diseases; this is the responsibility of those in charge of developing new drugs. Consequently, people who require these drugs have little or no access to them.

Palabras clave : clinical trial; infectious diseases; Peru; ethics; research; human rights.

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