Tables, listings and figures in a clinical study report - quality or quantity?

Abstract

In pharmaceutical industry, a prevalent yet problematic phenomenon is that piles of statistical tables, listings and figures (abbreviation TLFs) are prepared and included in a clinical trial study report (CSR). While some TLFs convey critical insights and others provide essential context to help reviewers understand the various properties of the drug, many other TLFs are redundant and serve no meaningful purpose. The overabundance of unnecessary TLFs in the CSR body or appendix can have several detrimental effects: it may confuse or mislead reviewers, obscure the key messages and waste valuable resources. This paper aims to shed light on this pervasive issue, highlight its potential adverse consequences and explore the underlying reasons. We will present two case examples to illustrate our points and offer practical solutions and recommendations. Finally, we will conclude this paper with a remark.