Clinical Trials in Cardiovascular Pharmacology in Argentina Between 2006 and 2010

Raúl Borracci, Martín R. Seoane, Julio Baldi (h), Carolina Granada, Hernán C. Doval

Abstract


We conducted a survey of pharmacological studies in the cardiovascular area to analyze the characteristics of clinical trials of cardiovascular diseases sponsored by pharmaceutical companies in Argentina. The studies included had been authorized by the ANMAT between 2006 and 2010. The information was retrieved from the ANMAT database. Of 1003 trials approved over that period, 120 (11.9%) belonged to the cardiovascular area. The number of studies decreased between 2006 and 2010 (r=0.79) as opposed to the increase observed in the number of clinical trials in other specialties. A total of 120 studies were analyzed; 68.3% were trials on hypertension, coronary artery disease, peripheral vascular disease or atrial fibrillation. Eighty seven percent of the participant centers were private institutions and only 13% were community- or public hospitals. Almost all the studies corresponded to clinical trials in phase II and III. Only two bioethics committees were responsible for the approval of almost 95% of trials. In conclusion, we found a reduction in the absolute and relative number of cardiovascular studies compared to other specialties. Nevertheless, Argentina remains in the second place behind Brazil in the number of clinical trials in the cardiovascular area, although the participation of clinical research organizations was higher and that of public hospitals was very low. The fact that only two bioethics committees were responsible for the approval of most studies might prevent an adequate monitoring of study outcomes.


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Revista argentina de cardiología. ISSN en línea 1850-3748. Argentine journal of cardiology (English ed. Online ISSN 2314-2286) Sociedad Argentina de Cardiología. Azcuénaga 980 (C1115AAD),Ciudad Autónoma de Buenos Aires, República Argentina. Tel. (54 11) 4961-6027/8/9 Fax: 4961-6020 www.sac.org.ar revista@sac.org.ar