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.

Setting-up a clinical trial: Some methodological recommendations

Pedroli E.;
2017-01-01

Abstract

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.
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11389/30779
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 0
  • ???jsp.display-item.citation.isi??? 0
social impact