685 - Does the PAAB have criteria when it comes to determining acceptability of high-quality meta analyses, with respect to clinical claims?

  • When assessing the acceptability of any study, “high quality” means that adequate steps have been taken to ensure that the observations are not due to random luck or systematic bias (whether methodological or confounding). This can only be assessed if the study report is comprehensive. For meta-analysis, we look to the PRISMA checklist, this checklists does not tell you whether a study is high-quality, but it does tell you what parameters one needs to know in order to make this assessment. Please note that a high-quality published and peer-reviewed meta-analysis can be considered as standalone evidence for disease information. Such meta-analysis can also be considered for therapeutic claims that are supported by individual RCT data presented in the APS (i.e. as additional evidence). It should also be noted that meta-analysis data from the TMA can be used in a manner that is consistent with the context and emphasis of the TMA presentation.