Current clinical research environment: focus on psychiatry

Abstract

A b s t r a c tThe introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/ scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area.Descriptors: Clinical research; Regulatory approval; Conflict of interest; Placebo; Clinical trial registration Resumo A introdução de diretrizes internacionais de Boas Práticas Clínicas, em 1996, imediatamente seguida pela publicação da Resolução do Conselho Nacional de Saúde 196/96, abriu uma grande oportunidade para a participação de centros de pesquisa brasileiros em estudos internacionais. Tais estudos devem ser estritamente monitorados, a fim de assegurar a adesão às legislações, assim como garantir a segurança dos pacientes envolvidos. A fim de evitar possíveis conflitos de interesse durante e após o estudo, todos os aspectos relacionados devem ser claramente definidos previamente entre o pesquisador, o patrocinador e a instituição. Aspectos operacionais, tais como tempo para aprovação regulatória do estudo, métodos de recrutamento e retenção de pacientes e a logística em geral, também são importantes. Em 2005, a Rede Nacional de Pesquisa Clínica foi criada no Brasil, somando a experiência de vários centros de pesquisa ligados a hospitais de ensino. Seu objetivo é reforçar a atividade de pesquisa clínica no país, com práticas atualizadas e adequado treinamento técnico-científico. O desenvolvimento de protocolos de pesquisa que foquem as prioridades de saúde do país é outro objetivo fundamental da Rede. Aspectos gerais da pesquisa clínica e algumas particularidades em Psiquiatria são discutidos no artigo. O objetivo final de todo o trabalho nesta área de pesquisa é, sem dúvida, a busca de melhores condições de saúde e qualidade de vida da população.

Randomised trials relevant to mental health conducted in low and middle-income countries: a survey

“…Most trials were small and few involved more than one country. The value of international trials has been demonstrated in cancer, heart disease and perinatal care; such studies enable large numbers to be recruited [ 14 ], ensure wide generalisability of results [ 15 ] and facilitate research capacity building [ 16 ]. Conducting large international trials in mental health would be likely to have similar advantages.…”

Cardiovascular risk factors in outpatients with bipolar disorder: a report from the Brazilian Research Network in Bipolar Disorder

“…18 This is of particular interest for the field of BD since most patients are treated by the public health system and prescription patterns may be different from the rest of the world, particularly regarding the use of atypical antipsychotics. 19 Despite being a leader in psychiatric research among developing countries, 20 one of the shortcomings that may constrain the progress of clinical research in Brazil is the relatively limited number of patients enrolled in most studies, and a natural step to overcome this limitation is to establish research networks. 21 In 2005, the Brazilian Association for Bipolar Disorder (ABTB) created the Brazilian Research Network in Bipolar Disorder (BRN-BD) as a means to promote the integration of BD research centers and to develop collaborative studies.…”