Guidelines for the Content of Statistical Analysis Plans in Clinical Trials
by Carrol Gamble, Ashma Krishan, Deborah Stocken, Steff Lewis, Edmund Juszczak, Caroline Doré, Paula Williamson, Douglas G. Altman, Alan Montgomery, Pilar Lim, Jesse Berlin, Stephen Senn, Simon Day, Yolanda Barbachano, Elizabeth LoderWhile 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. 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.
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
by Rafael Dal-Ré, Nicholas Katsanis, Sara Katsanis, Lisa S. Parker, Carmen AyusoGenome/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.