Resumo

PROVEYER DERICH, Samira; RODRIGUEZ MORALES, Ilys  e  ORTIZ REYES, Rosa María. Ensayos clínicos y buenas prácticas clínicas: una encuesta a especialistas del Instituto Nacional de Oncología y Radiobiología. Rev cubana med [online]. 2003, vol.42, n.4. ISSN 0034-7523.

The Good Clinical Practices are a set of internationally harmonized requirements that guarantee the protection of those subjects under investigation and allow that the generated data have the necessary scientific veracity to be accepted by the international and national regulatory agencies. The present paper was based on a survey done to evaluate the degree of knowledge of the specialists from the National Institute of Oncology and Radiobiology about Good Clinical Practices. The results obtained showed that the degree of knowledge on this topics is still deficient, excepting that of the specialists from the Experimental Drug Therapy Service that have carried out several clinical trials for years and have a wide experience on this regard. It was concluded that the measures should be directed to conduct training courses in Good Clinical Practices for the specialists that will take part in the new clinical trials with stage II and III biotechnological products that will be made next.

Palavras-chave : CLINICAL TRIALS [standars]; RESEARCH [estandars]; DATA COLLETION; PHISICIANS.