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Clinical trials

SUS requirements

Research network in teaching hospitals expanded

Eduardo CesarAt the end of 2009, the ministries of Health and Science & Technology announced an expansion of the National Network of Clinical Research in Teaching Hospitals (RNPC), whose structure has gone from 19 to 32 centers nationwide. The network that was created in 2005 has a dual objective. On the one hand, it seeks to institutionalize clinical research in teaching hospitals in various places in Brazil, thus ensuring they gain competence in carrying out clinical trials, an expertise that until a short time ago was limited to hospitals in large metropolises. On the other, it emphasizes public health demands, by testing drugs, procedures and devices for diagnosing diseases that are of interest to the Single Health System (SUS). “The idea of the network is to give the SUS a chance of having clinical studies that meet their particular needs”, says the Secretary of Science, Technology and Strategic Inputs at the Ministry of Health, Reinaldo Guimarães. “Until a few years ago contracting clinical study protocols by pharmaceutical companies was habitually carried out under private standards, directly with a researcher and without any institutional intervention, despite the fact that the research used the infrastructure and personnel from public institutions. With the collaboration of universities and hospitals this practice tends to be residual nowadays”, he says.

According to Guimarães, the network does not intend to interfere with the direct relationship between pharmaceutical companies and researchers, but offers an institutional alternative whose goal is public interest. “Appropriation of the technology involved in clinical trials is not normally provided in the protocols entered into by pharmaceutical companies”, he says. “In these cases the team receives a protocol that is signed and sealed, acquires patient information and sends it to a center outside the country. Very little is learned”. According to a survey carried out by the Department of Science and Technology of the Ministry of Health in 2006 and 2007 942 clinical research projects were started in 16 of the 19 centers that then participated in the network. The SUS financed 113 of them, 380 were funded by federal and state development agencies and 337 by private companies. In the first three years of operation, the network received investments of R$ 35 million. No additional funds for expanding it are predicted.

Tradition
The RNPC brings together institutions that have a tradition in clinical trials, such as the Hospital das Clínicas from the Medical School at the University of São Paulo (FMUSP), whose research ethics committee receives around 1000 protocols a year to assess and whose adherence to the network has resulted in improvements in the already existing structure of hospital units that have recently started to take part in trials. An example is the João de Barros Barreto University Hospital of the Federal University of Pará that, with financial resources received from the network, has developed a clinical research unit that is integrated with the university’s other investigation centers. “This integration is healthy. With networking the more traditional institutions pass on their experience to the others”, says Reinaldo Guimarães.

One of the examples of research of interest to SUS carried out by the network is a study that is looking to identify patients with resistant hypertension from among the regional diversities of the Brazilian population and to determine the best therapeutic approach to this subgroup. The study involves 25 Brazilian institutions and is being coordinated by Eduardo Moacyr Krieger from FMUSP’s Institute of the Heart. It comprises the study of 2000 patients over a 12-month period, in which treatment guidelines are followed, using SUS drugs and infrastructure to identify those patients who are resistant to conventional treatment with up to three drugs against hypertension. Another prominent project is Prever (Prevention of cardiovascular events in patients with pre-hypertension and arterial hypertension). The objective of this study, which is coordinated by Professor Flavio Fuchs from the Federal University of Rio Grande do Sul, is to compare by means of clinical trials the effectiveness of the association of the two drugs, chlortalidone and amiloride in low doses, for preventing cardiovascular disease and systemic arterial hypertension in patients with arterial pre-hypertension. It is also looking to compare the effectiveness of the drug, losartan potassium, with the association of chlortalidone and amiloride in the prevention of cardiovascular events in patients with severe arterial hypertension. “These two projects show the interest there is in developing a multicenter in clinical research network, training professionals to prepare projects and collecting data to respond to issues of social relevance that are of interest to the health manager and not to pharmaceutical companies”, says Guimarães.

One of the new centers to join the network is the Nossa Senhora da Conceição Hospital (HNSC), from Tubarão (SC). According to Daisson José Trevisol, who is a member of the Department of Teaching and Research of the HNSC and coordinates the hospital unit of the Sul de Santa Catarina University (Unisul), a non profit community institution, it is expected to expand the clinical research possibilities both of the university as well as the hospital, by training and equipping research centers. “We hope to make research self-sustainable, allowing our students to learn how to research so that our professors can publish articles in international journals of impact in the scientific community”, he stated.

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