Sponsored multicentric clinical research conducted in Brazil in the respiratory area - losses and gains

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da Silveira Carvalho, Andrea Kelly
Nascimento, Oliver Augusto
Machado Fonseca, Marcelo Cunio [UNIFESP]
Barros Pereira, Eanes Delgado
Jardim, Jose Roberto [UNIFESP]
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Objective: To evaluate the sponsored centers for clinical trial in the respiratory care setting in Brazil: profile; logistics and structure. Methods: Principal investigators (29) and subinvestigators (30) of 39 research centers completed the questionnaires that addressed personal identification and training of researchers, the centers' facilities and advantages and/or disadvantages of performing sponsored trials. Results: 75.6% of the centers were located in southern and southeastern Brazil. Most principal investigators were men with a mean age of 53.4 years. The clinical trials in the respiratory care setting focus on asthma and chronic obstructive pulmonary disease (COPD). 80% of the researchers cited delay of the Conep and Anvisa as a barrier to performing research. The advantages of participating in clinical trials were updating knowledge of the researcher and the team, and additional income for the team. The main disadvantages mentioned by the researchers included low financial compensation for the performed workload, and time availability. The median number of professionals per research center was six people, predominantly physicians. Conclusion: The number of research centers in the respiratory care setting in Brazil is still relatively small. The teams have good training for performing the clinical trials. Asthma and COPD are the most studied diseases in sponsored clinical trials. The main barrier is delay by the Conep and Anvisa. The factors that lead investigators to participate range from being updated along with the team, to site and staff financial issues; the main disadvantage is the low compensation for the required workload demand.
Revista Da Associacao Medica Brasileira. Sao Paulo, v. 62, n. 2, p. 131-137, 2016.