From Richard Platt to Dandan:

Dandan,
I see Ken is away.  As a placeholder, you may find worthwhile material on this page:
https://sites.duke.edu/rethinkingclinicaltrials/biostatistical-guidance-documents/

Your non-statistician colleagues might also be interested in this JAMA article:
http://jamanetwork.com/journals/jama/article-abstract/2297149

Rich


Review of informed consent in pragmatic RCTs: https://www.jclinepi.com/article/S0895-4356(19)30344-0/fulltext?rss=yes