Commentary on Fleming et al.: Data monitoring committee evidence base needed

Fleming T DeMets D Roe M . Data monitoring committees: promoting best practices to address emerging challenges. Clin Trials, in press.

US Department of Health and Human Services, Food and Drug Administration. Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees, http://www.fda.gov/downloads/regulatoryinformation/guidance/ucm127073.pdf (2006, accessed 30 November 2016).

National Heart, Lung, and Blood Institute, National Institutes of Health. Data coordinating center for multi-site investigator-initiated clinical trials (Collaborative U24). FOA PAR-16-301, October 2016. Bethesda, MD: National Institutes of Health.

Wittes J Barrett-Connor E Braunwald E . Monitoring the randomized trials of the Women’s Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials 2007; 4: 218–234.

Fisher RA . Mathematics of a lady tasting tea. In: Newman JR (ed.) The world of mathematics. New York: Simon & Schuster, Inc., 1956, pp. 1512–1521.

Hudson KL Lauer MS Collins FS . Toward a new era of trust and transparency in clinical trials. JAMA 2016; 316: 1353–1354.