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282 - In the new PAAB code, it says: "The PAAB can allow the use of observational studies when specific acceptance criteria are met." What are the specific acceptance criteria? Also, does a natural history study fall under an 'observational study' or 'meta-analysis'? Thanks
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A natural history study is a type of observational study which simply follows a group of people (e.g. on a drug or having a condition) over time. They tend not to have a control group and thus would not be considered as evidentiary support for claims in drug advertising. A high quality cohort study or case-control study can be considered as evidence for adherence claims. These two groups of non-experimental trials can also be considered corroborating evidence for therapeutic claims of efficacy and safety. The guidance document on our website provides more information on observational studies. For any analysis (including observational studies and meta-analyses) "high quality" means that adequate steps were 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 observational studies we look to the STROBE checklist, for meta-analysis we look to the PRISMA checklist. These checklists do not tell you whether a study is high-quality, but they do tell you what parameters one needs to know in order to make that assessment.
