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.

1st February 2018 • comment
11th November 2016 • comment

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

8th February 2016 • comment

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

by Rafael Dal-Ré, Nicholas Katsanis, Sara Katsanis, Lisa S. Parker, Carmen Ayuso

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.

15th January 2014 • comment

Social science guidance from the ACT Consortium available for wider research community, including training materials, SOPs, template protoclos and other tools.

13th January 2014 • comment