Résumé
Con el objetivo de analizar las características de los ensayos clínicos farmacológicos patrocinados por la industria en el área de las enfermedades cardiovasculares en la Argentina, se efectuó una búsqueda de los estudios farmacológicos realizados en el área de la cardiología, autorizados por la ANMAT entre 2006 y 2010, mediante la base de datos pública de dicho organismo. De 1.003 ensayos aprobados en ese período, 120 (11,9%) pertenecían al área de las enfermedades cardiovasculares. Se observó una reducción en términos absolutos del número de estudios entre 2006 y 2010 (r = 0,79), tendencia que se contrapuso al aumento de los ensayos clínicos observado en otras especialidades. De los 120 estudios analizados, el 68,3% pertenecían a ensayos sobre hipertensión, enfermedad coronaria, enfermedad vascular periférica o fibrilación auricular. Del total de centros participantes, el 87% correspondió a entidades privadas y sólo el 13% a hospitales comunitarios o públicos. Casi la totalidad de los estudios correspondieron a las fases II y III de investigación clínica y sólo dos comités de bioética fueron responsables de la aprobación de casi el 95% de los ensayos. En conclusión, los estudios del área cardiovascular han mostrado una reducción en su número absoluto y relativo con respecto a otras áreas. Pese a ello, la Argentina mantiene el segundo puesto en cantidad de ensayos cardiovasculares detrás de Brasil, aunque con una injerencia mayor de las organizaciones de investigación clínica y una participación menor de los hospitales públicos. La alta concentración de aprobaciones de estudios en sólo dos comités de bioética impediría un control adecuado de la evolución de los protocolos.
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.
Résumé
FUNDAMENTO: Existem evidências de que algumas vezes os requisitos de aprovação do Conselho de Revisão Institucional (IRB) e obtenção de termo de consentimento livre e esclarecido (TCLE) para a realização de pesquisas com seres humanos não são cumpridos nas publicações argentinas de pesquisas cardiovasculares. OBJETIVO: Analisar a freqüência com que a aprovação do IRB e o TCLE são obtidos na Argentina. MÉTODOS: Pedimos que cem autores de artigos apresentados no nosso encontro científico de 2006 respondessem a um questionário. RESULTADOS: Trinta e seis por cento dos questionários foram devolvidos com confirmação de revisão ética, 34 por cento responderam que não havia sido feita, 23 por cento disseram que tinham sido isentados da revisão e 7 por cento não foram devolvidos. A maioria dos artigos submetidos à revisão era de estudos farmacológicos ou pesquisas sobre avaliação de novos dispositivos. A maioria dos artigos que não passaram por revisão ética era referente a pesquisas epidemiológicas ou estudos para avaliação de métodos não-invasivos; 60 por cento dos estudos farmacológicos, implante celular ou avaliação de novos dispositivos atendiam às exigências das normas federais. CONCLUSÃO: A taxa de revisão ética e a obtenção do TCLE nas publicações argentinas de pesquisas cardiovasculares varia entre os artigos. A maior parte das pesquisas referentes a estudos observacionais prospectivos e cerca de 50 por cento dos protocolos de intervenções ou procedimentos invasivos não relatam a realização de revisão ética. Essa porcentagem elevada de artigos que não são submetidos à revisão ética indica a existência de falhas legais e éticas que devem ser discutidas e corrigidas.
BACKGROUND: Requirements for Institutional Review Board approval and informed consent for research involving human subjects have existed for more than 2 decades. However, evidence of fulfillment of these requirements is sometimes lacking in cardiovascular research reports in Argentina. Since ethical standards vary between committees, there may be some confusion among researchers regarding the need for an ethical review when conducting low risk research. OBJECTIVE: To examine the frequency of obtaining an ethical review and informed consent in cardiovascular research in Argentina. METHODS: Through a questionnaire, we contacted authors of 100 reports submitted to our annual scientific meeting during 2006. RESULTS: Thirty six per cent of questionnaires were resubmitted with confirmation of ethical review, 34 percent responded that ethical review was not obtained, 23 percent reported as being exempt and 7 percent were never resubmitted. Most articles obtaining ethical review were pharmacological trials or research involving assessment of new devices. On the other hand, most articles reporting lack of or exemption from ethical review come from epidemiological research or studies evaluating non-invasive methods. Sixty percent of phase IV pharmacological trials, research on cellular implantation or assessment of new devices met federal regulations requirements. CONCLUSION: The rate of ethical review and use of informed consent in cardiovascular reports in Argentina vary among articles. Most research involving prospective observational studies and nearly 50 percent of protocols including intervention or invasive procedures do not report ethical review. This high proportion of articles lacking ethical review suggests the presence of legal and ethical flaws which should be discussed and overcome.