What differentiates clinical trial statistics from preclinical methods and why robust approaches matter.

Abstract

Clinical trial statistics underlie the central decision-making process for whether a therapeutic approach can enter the clinic, but the nuances of this field may not be widely understood. Furthermore, how the statistics used in clinical trials differ from preclinical approaches and why they differ is not always clear. Here, three experts discuss the intricacies of clinical trial statistical planning and analysis as well as common issues that arise and emerging trends. The experts are Dr Tao Chen (Senior lecturer in Biostatistics at the Liverpool School of Tropical medicine), Professor Li Chao (Professor in Biostatistics at Xi’an Jiaotong University) and Professor Yang Wang (Professor in Biostatistics at the Chinese Academy of Medical Sciences and Peking Union Medical College). They have a diverse range of backgrounds across biostatistics and have been involved in numerous clinical trials of varying types.