Clinical trials approved by the National Health Surveillance Agency

Objective. To describe the main features of clinical trials approved in 2005 and to examine associations between these characteristics and the phases of clinical trials. Method. A cross sectional survey with analysis of data obtained from the files of the division of Management Research, Clinical Trials and New Drugs of the Agency. Results. In the mentioned year, 198 clinical trials were approved. The majority was submitted by pharmaceutical companies, 92% were multicentric and around 80% provided for the participation of up to 8 centers of research inBrazil. Studies of phase III (54%), randomized (75%), double-blind (52%) and with parallel groups (79%) had predominated.Few studies were labeled phase I (5%). The one investigated the most within the therapeutic group was the antineoplasics (18%). No association was found between multicenter studies and stages of research. Phase I isassociated with non-randomized studies, with no blinding nor control group. Phase III is associated with randomization,double-blind evaluation and parallel control group. Phase IV is associated with simple-blind. Conclusions. More clinical trials in early stages to be developed in Brazil are required to incorporate the technologyfor the development of new drugs. Encouraging domestic production of medicines and search for new molecules can be viable strategies. Further studies are needed to verify whether the clinical trials conducted in Brazil are in accordance with the national epidemiologic demand.