Methodological quality and reporting of ethical requirements in clinical trials

Methodological quality and reporting of ethical requirements in clinical trials.

OBJECTIVES To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. DESIGN Systematic review using a standardised checklist. MAIN MEASURES Methodological and ethical issues of all trials published between 1993 and 1995 in the New Englan...

CLINICAL ETHICS Methodological quality and reporting of ethical requirements in phase III cancer trials

Background: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. Method: Methodo...

Methodological quality and reporting of ethical requirements in phase III cancer trials.

BACKGROUND The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD Methodo...

Methodological Reporting of Randomized Clinical Trials

BACKGROUND: Although randomized controlled trials (RCTs) are considered the highest level of evidence, they are also subject to bias, due to a lack of adequately reported randomization, and therefore the reporting should be as explicit as possible for readers to determine the significance of the contents. We evaluated the methodological quality of RCTs in respiratory research in high ranking cl...

Cluster randomised trials : Methodological and ethical considerations