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Acta Cir Bras. 2008 Nov-Dec;23(6):531-5.

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

Author information

  • 1Sao Camilo University Center, Sao Paulo, Brazil. vanessabrick@hotmail.com

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.

PMID:
19030752
[PubMed - indexed for MEDLINE]
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