Monday, December 16, 2013
FDA's forthcoming guidance on the design and conduct of
meta-analyses should help the agency determine when to dedicate resources to
reviewing such studies or using them as the basis for regulatory action. But to
prevent flawed studies from causing public health crises, medical journals will
need to adopt quality guidelines for publishing meta-analyses, as well.
FDA intends the guidance to
provide a consistent framework for designing, analyzing, reporting and
interpreting meta-analyses conducted by companies or FDA, as well as any
unrequested meta-analyses submitted to FDA by third parties.