[What is being investigated and who conducts clinical research related to medicines in Argentina?]

Abstract

Introduction: Clinical trials that involve medicines are performed in order to determine their effectiveness and safety. In Argentina, these studies are presented either to National Administration of Drugs, Food and Medical Technology (ANMAT) to obtain drug registration, or to the National Ministry of Health (MSAL) (to obtain the official recognition). This work was carried out to increase the knowledge about the clinical trials performed in Argentina.

Materials and methods: The MSAL/ANMAT databases were explored. The variables were: dates of request, institution, phase of the study, enrollment modality, product investigated, therapeutic group, comparator, pathology involved, and location of laboratory performance.

Results: A total of 201 protocols were detected in the period of study, all of them performed with registration purposes. Twenty pharmaceutical companies carried out 60% of the studies (17 with foreign capital). Seventy percent were phase III (90% multicenter protocols). Three out of 4 trials corresponded to the oncology / immunosuppressant therapeutical group. In 65% the comparator used was placebo. A 71% of the studies were carried out in health institutions of Buenos Aires City. Ninety-eight per cent of laboratory controls were carried out abroad.

Discussion: Foreign pharmaceutical companies are the only ones that carry out clinical trials on medicines in Argentina, all of them for registration purposes. The use of placebo as a comparator is inappropriate, since each drug is expected to be validated against another of recognized efficacy already available in the market. Oncological/immunological pathologies are the ones that arouse greater interest among local researchers due to their prevalence and their greater profitability in the pharmaceutical market.