Setting-up a clinical trial: Some methodological recommendations

• Desirée Colombo ^[2] ; Pietro Cipresso ^[2] ; Elisa Pedroli ^[2] ; Giuseppe Riva ^[1]
  1. [1] Catholic University of the Sacred Heart

     Catholic University of the Sacred Heart

     Milán, Italia

     
  2. [2] IRCCS Istituto Auxologico Italiano (Italia)
• Localización: Anuario de psicología, ISSN 0066-5126, Vol. 47, Nº. 3, 2017, págs. 130-139
• Idioma: inglés
• DOI: 10.1016/j.anpsic.2017.12.001
• Títulos paralelos:
  • Creación de un ensayo clínico: algunas sugerencias metodológicas
• Enlaces
  • Texto completo
• Resumen
  • español

    Los ensayos clínicos bien disenados ˜ son el estándar por excelencia para la investigación basada en la evidencia y para la evaluación de la eficacia de una intervención clínica.

    Las directrices metodológicas se encuentran disponibles en varias fuentes, tales como libros de texto, solicitudes de financiamiento y directrices institucionales. Sin embargo, un gran número de ensayos publicados todavía carecen de rigor metodológico, disminuyendo su utilidad, calidad y validez científica. En este artículo, nuestro objetivo es proporcionar algunas recomendaciones metodológicas para el desarrollo e informe de un ensayo clínico, incluyendo la definición y selección de la muestra, los disenos ˜ básicos de estudio, la aleatorización, el cegamiento, el análisis y el reporte de datos. Finalmente, discutiremos algunas de las consideraciones éticas más importantes.

  • English

    Well-designed clinical trials are the gold standard for evidence-based research and for the assessment of the effectiveness of a clinical intervention. Methodological guidelines are available from various sources, such as textbook, funding applications and institutional guidelines. Nevertheless, a high number of published trials still lack methodological rigor, decreasing their utility, quality and scientific validity. In this article, we aim at providing some methodological recommendations for the development and report of a clinical trial, including the definition and recruitment of the sample, the basic study designs, randomization, blindness, data analysis and data report. Finally, we will discuss some of the most important ethical issues.

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