The biostatistician figure on Ethics Committees (EC)Guidelines for the role of the biostatistician and for the activityof the biostatistician in the review of the protocols ofthe biostatistician in the review of the protocols of thestudies proposed for the consideration of the EC

• Autores: Bruno Mario Cesana, Elia Mario Biganzoli
• Localización: Medicina y Ética: Revista internacional de bioética, deontología y ética médica, ISSN-e 2594-2166, ISSN 0188-5022, Vol. 29, Nº. 1 (ene-marzo/January-March), 2018, págs. 111-141
• Idioma: inglés
• Títulos paralelos:
  • La figura del bioestadístico en los Comités Éticos (CE). Líneas guía para el rol del bioestadístico y para la actividad del bioestadístico en la revisión de los protocolos de los estudios propuestos a la consideracion de los CE
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• Resumen

  • The biostatistician figure on Ethics Committees (EC)Guidelines for the role of the biostatistician and for the activityof the biostatistician in the review of the protocols ofthe biostatistician in the review of the protocols of thestudies proposed for the consideration of the EC main field of knowledge concerning the protocols submitted to EC.As regards to experimental studies, this field of knowledge inclu-des subjects such as randomization, definition of target popula-tion, identification of endpoints, variable detection, formalizingstatistical hypotheses to calculate sample size. Aspects relating tothe development of the statistical analysis plan are considered aswell. Finally, several experimental and observational studies withtheir specific methodological statistical aspects are reflected uponalong with the actions given to the BS on EC to carry out his/heractive contribution in the evaluation and discussion of EC.