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

Abstract

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.

Study of Dabigatran Use in a Brazilian Public Hospital Specialized in Cardiology

“…12 In Brazil, dabigatran etexilate is not distributed by the Unified Health System (SUS), nor is it standardized in many hospitals, which hinders the monitoring of its use. Thus, the objective of the present study includes the assessment of safety, effectiveness, and adherence to dabigatran prescribed to non-valvular atrial fibrillation in a public Brazilian hospital, specialized in cardiology, by characterizing the profile of adverse events.…”