Meta-Analytic Models

Data available from the public domain including the literature and summary basis of approvals (SBAs) for competitor drugs can be useful to complement an organization's own in-house data when making drug development decisions. Data from these sources are typically reported at a summary level (e.g. means and standard deviations) as individual subject level data are typically not available in the public domain. Models taking into account the statistical issues of pooling summary level data from various studies and public sources are referred to as meta-analytic models. These models are useful for understanding the competitive landscape, estimating placebo responses under different experimental conditions (entry criteria), and to inform target values for decision criteria, to name a few.