Recruitment of subjects in industry-sponsored multicenter international clinical trials

  • Rodrigo Batagello Pontifícia Universidade Católica do Paraná. Programa de PósGraduação em Bioética
Keywords: Patient Selection, Clinical Trial, Multicenter Study, International Cooperation, Research Subjects

Abstract

This study concerns the recruitment of research subjects in industry-sponsored multicentric international clinical trials carried out at a Brazilian public university between January 2010 and December 2016. A set of 63 clinical trial agreements, administrative and regulatory documents was analyzed. The results showed that 75 countries were involved in these international trials, of which 16% were Latin American. Data about the recruitment of research subjects at the local (356 subjects), national (3774 subjects) and international (82,696 subjects) levels were obtained, as well as information on the number of Brazilian research centers involved and the costs of each trial. Phase III trials were the most frequent (77.78% of the cases) and they estimated a total national enrollment between 18 and 80 research subjects per trial (which means between 4.42% and 11.46% of international recruitment). A negative correlation was found between agreements, research resources, recruitment data, and yearly average dollar exchange rate. All the trials adopted competitive recruitment method associated with payment for subject included in the research. This is worrying and shows contradiction between this practice and the recommended national ethical guidelines. The lack of data on recruitment at the national level reveals, in 19% of the cases, a frequent regulatory process failure. It is concluded that the availability of detailed data on recruitment for researches involving human beings is important for the accurate sizing and organization of the efforts to protect research subjects, and that currently this premise is not being appropriately followed.

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Published
2019-01-18
How to Cite
Batagello, R. (2019). Recruitment of subjects in industry-sponsored multicenter international clinical trials. Saúde E Sociedade, 27(4), 1033-1043. https://doi.org/10.1590/s0104-12902018180292
Section
Articles