William Saad Hossne

Clinical research on new drugs (Phase I). Profile of scientific publications: data from the pre-clinical phase and bioethical aspects

PURPOSE To trace a profile of scientific publications, phase I, in order to know whether or not they show pre-clinical phase data, emphasizing bioethical aspects. METHODS Sixty-one scientific articles, published in 2007, involving research in human beings using new drugs, medicines and vaccines during phase I were analysed. A schedule for data collection was elaborated in which it would be possible to analyse and evaluate those articles. The schedule included items related to the pre-clinical phase associated to the clinical phase, and items related to the sample characteristics. RESULTS Most of research works were carried out in USA. Taking into consideration that a large number of works have been dedicated to oncologic affections, most of them were carried out in voluntary ill individuals. Information on the pre-clinical phase, phase I, was very poor or absent. Even though some authors consider the phase I research as a promising one and also suggest some future studies on phase II, the reader is not able to consider the same way, as long as there is a shortage of information on the pre-clinical phase. CONCLUSION The profile of scientific publications showed that data deserve some reflections and analysis to better evaluate the publications on phase I.

Ethics of Research Involving Human Subjects: The Brazilian Experience

Human experimentation cannot be analyzed in isolation because many forces shape social interaction - man’s quest for knowledge and mastery, his willingness to risk human life, and his readiness to delegate authority and to rely on professional judgment (Katz 1972). It was man’s capacity for seeking justice that made ethics committees possible, while at the same time it was man’s capacity for deceiving people that made ethics committees necessary (Ramsey 1982, p. 533). As Raul Hilberg wrote in The Destruction of the European Jews, “If the world was so shocked at what it discovered to be the extremes to which experimental medicine would go, it has yet to condemn the method or find the means to control it” (Hilberg 2003). From our point of view, the right choice is to control experimentation on human beings.

Brazil: The System for the Protection of Voluntary Participants in Research

Brazil’s involvement in international clinical research grew in the 1980s when its public hospitals and academic medical centers joined European and American investigators. The country’s return to democracy and the documentation of ethical abuses while conducting clinical trials triggered the need to develop norms and regulations.