Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases
by Honghui Zhou, Diane R. Mould
55Model‐Based Meta‐Analysis Use in the Development of Therapeutic Proteins
Timothy J. Taylor Bill Frame and Angela D. Taylor
Projections Research Inc., Pharmacometrics, 63 E. Shore Drive, Niantic, CT, 06357, USA
5.1 Introduction
Model‐based meta‐analysis (MBMA) is a method for combining summary or aggregate qualitative and quantitative study data from multiple studies to develop a single conclusion that has greater statistical power than one study alone, thus facilitating decisions during drug development. Individual studies sometimes fail to show statistically significant differences; multiple studies investigating the same clinical hypothesis often form a continuum of clinical experience and combining these study results leverages existing information. Since MBMA is based on aggregate (e.g. mean or median) results from large numbers of subjects from different studies and potentially different therapeutic agents, it increases the power to precisely detect significant effects across multiple studies, providing a basis for quantitative drug development decisions [1].
The term meta‐analysis was introduced by Glass in 1976 where in his paper on educational research he states, “Meta‐analysis refers to the analysis of analyses” [2]. The basic idea is to combine results from multiple scientific studies and analyze that data together as a whole. British mathematician Karl Pearson was the first to apply this method while reporting on inoculations to prevent enteric fever due to Salmonella ...