Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods

Chapter 54

Trial Reports: Improving Reporting, Minimizing Bias, and Producing Better Evidence-Based Practice

Larissa Shamseer, Lucy Turner and David Moher

“Failure to publish an adequate account of a well-designed clinical trial is a form of scientific misconduct which can lead those caring for patients to make inappropriate treatment decisions.”—Sir-Iain Chalmers, 1990

54.1 Introduction

Data from research studies can only be effectively translated into maximum health benefits when they are presented in an accurate, complete, and usable format. Such clarity enables readers to understand exactly how the research was conducted, what was found, how reliable the findings are, and how they fit into the wider context of existing knowledge. The current state of reporting of randomized controlled trials (RCTs) is unfortunately dismal, with evidence of only minor improvements over the last few decades [1,2]. Problems with reporting of clinical trials first started being documented in the 1960s [3], approximately 30 years after the emergence of the modern clinical trial—RCT [4]. Today, a number of problems with trial reporting are known to exist, and documentation of these problems has been accruing over time.

54.2 Reporting Issues in Clinical Trials

54.2.1 Incomplete Reporting of Trial Methods

In the early 1990s, JAMA was among the first to voice concerns over the reporting of trials by publishing a study showing that most trials do not report a sample size calculation [5], in agreement ...