Methods

This document aims to improve research quality and coordination to identify and propose best practices and other measures to strengthen the global clinical trial ecosystem and to review existing guidance and develop new guidance as needed on best practices for clinical trials.

Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Trial registration, protocols, and statistical analysis plans are critically important in ensuring appropriate reporting of clinical trials.

Adaptive trial design has been proposed as a means to increase the efficiency of randomized clinical trials, potentially benefiting trial participants and future patients while reducing costs and enhancing the likelihood of finding a true benefit, if one exists, of the therapy being studied.

The objective of the study was to outline key considerations for general clinical readers when critically evaluating publications on platform trials and for researchers when designing these types of clinical trials.

In this review, using a series of examples derived from equivalence and non-inferiority/superiority RCTs, we describe the main differences and methodological aspects among these three different types of RCTs

This paper is a practical guide to the essentials of statistical analysis and reporting of randomized clinical trials, include statistical controversies in reporting and interpretation, the fundamentals of trial design, and statistical challenges in the design and monitoring.