Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

Abstract Importance  While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Objective  To develop recommendations for a minimum set of items that should be addressed in SAPs for clinical trials, developed with input from statisticians, previous guideline authors, journal editors, regulators, and funders.

Wellcome and Open Research

Sharing outbreak research data

Recent calls have been made for rapid and responsible sharing of research data in public health emergencies and outbreaks.

Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the principle of justice

Genome/exome data are likely to play an increasing role in clinical trials, and incidental findings are likely to be viewed as potential benefits for individuals of research participation.