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Methodological guideline for REA of pharmaceuticals: Internal validity

Methodological guideline for REA of pharmaceuticals: Internal validity

This guideline focuses on the assessment of the risk of bias of randomized controlled trials (RCTs), the most relevant trials for relative effectiveness assessment (REA) of pharmaceuticals. The quality assessment of non-randomized and diagnostic accuracy studies will be elaborated in separate guidelines. Likewise, a separate guideline deals with the problem of assessing applicability.

Internal validity describes the extent to which the (treatment) difference observed in a trial (or a meta-analysis) is likely to reflect the ‘true’ effect within the trial (or in the trial population) by considering methodological quality criteria. Because the ‘truth’ can never be assessed, it is more appropriate to speak of the potential for or risk of bias.

Please find the guideline on internal validity at the bottom of this page


Full list of guidelines

This document is part of the JA1 Final Technical Report as Deliverable
“D3-2 WP5_3a8_Internal_Validity”
NOTE: For the full Technical Report, please follow this link
.

Internal_Validity

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