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


CONCLUSIONS
The profile of scientific publications showed that data deserve some reflections and analysis to better evaluate the publications on phase I.
Brick
Vanessa de Souza
Vde S
Sao Camilo University Center, Sao Paulo, Brazil. vanessabrick@hotmail.com
Hossne
William Saad
WS
Saad Hossne
Rogério
R
D000818:Animals; D035843:Biomedical Research / Q000941:ethics*; D001938:Brazil; D017321:Clinical Trials, Phase I as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical / Q000941:ethics*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D004364:Pharmaceutical Preparations; D012107:Research Design; D012108:Research Personnel; D014481:United States
D004364:Pharmaceutical Preparations