The 2008 Draft FDA guidance on the ISE

The 2008 Draft FDA guidance on the ISE

The 2008 Draft FDA guidance on the ISE provided in this session provides a lot of detail on pooled analyses (also
referred to in the guidance as “meta-analyses”). Based on the information in this guidance, what are the benefits
of pooling efficacy data across studies? What might be some of the inherent problems in pooling data (including  factors that would prevent pooling)?
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