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.
Recent calls have been made for rapid and responsible sharing of research data in public health emergencies and outbreaks.
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.
Social science guidance from the ACT Consortium available for wider research community, including training materials, SOPs, template protoclos and other tools.