Meta-análisis - Web de Ferran Torres

ICH Biostatistical guideline
”Individual clinical trials should always be large
enough to satisfy their objectives.”
”The
use of meta-analytic analytic techniques to
combine these estimates is often useful,
because it allows a more precise estimate of
the size of the treatment effects.”
ICH Biostatistical guideline
”Under
exceptional circumstances a meta-
analytic approach may be the most
appropriate way to, or the only way, , of
providing sufficient overall evidence of
efficacy ...”
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PtC on Meta-analyses
analyses
Acceptable regulatory purposes for meta analysis
”… not to encourage applicants to rely on a
submission where stand alone studies
have been substituted by a meta-
analysis of trials of inadequate size.”
To improve the precision of the estimate of
efficacy
To evaluate whether overall positive results
are also seen in pre-specified subgroups
To evaluate apparently conflicting results.
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2007 Ferran.Torres@uab.es 82
Acceptable regulatory purposes for meta
analysis
To evaluate an additional efficacy outcome
that requires more power than the individual
trials can provide.
To evaluate safety in a subgroup, , or a rare
event in all patients.
Pre-specification
specification: : Meta-analysis analysis protocol
The objective of the analyis.
Criteria for inclusion and exclusion of studies
(study
populations, study design, dosage,
duration etc).
Strategy for indentification of studies.
Endpoints. . The definitions set up for the
individual studies should be followed.
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2007 Ferran.Torres@uab.es 84
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