Resumo

ROBAINA GARCIA, Maytee  e  FORS LOPEZ, Martha María. Role of statistics in the clinical trials. Rev Cubana Farm [online]. 2011, vol.45, n.4, pp. 575-585. ISSN 0034-7515.

The complexity and high costs associated to the development of drugs have brought about the search for more efficient strategies combining time saving and research quality. The statistical methodology plays a fundamental role in this process. The present paper made a literature review of the role of statistics in therapeutic research. The objectives were to describe how statistics participate in the clinical trials and to present some advances attained as well as the challenges met by the biostatician in the present context of development of these studies. The statistical process was described in the clinical trial from the practical viewpoint, including regulatory demands and documentary availability. Some specific methodological topics as well as application-developed statistical techniques were presented. It was concluded that the statistical methodology in clinical trials has experienced growing development in the last few years. The research suggested the use of flexible designs that would speed up the most sensitive studies and methods of analysis. The regulatory bodies set guidelines that give instructions for the harmonized presentation of clinical trials under various circumstances. The application of more sensitive statistical techniques and the use of technologies supporting these advances is a subject that is increasingly dealt with by the scientific literature on clinical trials.

Palavras-chave : drug development; clinical trials; clinical trial design; statistical methodology; statistical techniques in clinical trials.

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