University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding data and safety monitoring committees in clinical trials (morning panel session)

Fleming TR DeMets DL Roe MT et al . Data monitoring committees: promoting best practices to address emerging challenges. Clin Trials 2017; 14: 115–123.

Calis KA Archdeacon P Bain RP et al . Understanding the functions and operations of data monitoring committees: survey and focus group findings. Clin Trials 2017; 14: 59–66.

Calis KA Archdeacon P Bain R et al . Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative. Clin Trials 2017; 14: 342–348.

Clinical Trials Transformation Initiative, https://www.ctti-clinicaltrials.org/ 2018 (Accessed 16 January 2018).

Ellenberg SS Fleming TR DeMets DL. Data monitoring committees in clinical trials. Chichester: Wiley, 2002.

Herson J. Data and safety monitoring committees in clinical trials. Boca Raton, FL: Taylor & Francis, 2009.

O’Brien PC Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35: 549–556.

Lan KKG DeMets DL . Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659–663.

CITI Program. Human subjects research (HSR), https://about.citiprogram.org/en/series/human-subjects-research-hsr/ (Accessed 5 February 2018).

DeMets DL Fleming TR Rockhold F et al . Liability issues for data monitoring committee members. Clin Trials 2004; 1: 525–531.

Meinert CL. Masked monitoring in clinical trials—blind stupidity? N Engl J Med 1998; 338: 1381–1382.

ClinicalTrials.gov protocol registration data element definitions for interventional and observational studies, https://prsinfo.clinicaltrials.gov/definitions.html 2017 (Accessed 5 February 2018).

DeMets DL Furberg CD Friedman LM (eds). Data monitoring in clinical trials: a case studies approach. New York: Springer, 2006.

Fleming TR Ellenberg SS DeMets DL. Data monitoring committees: current issues. Clin Trials. Epub ahead of print 9 April 2018. DOI: 10.1177/1740774518764855.

Bombardier C Laine L Reicin A et al . Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343:1520–1528.

Curfman GD Morrissey S Drazen JM . Expression of concern: Bombardier et al., “Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis,” N Engl J Med 2000;343:1520-8. N Engl J Med 2005; 353: 2813–2814.

National Public Radio, Inc. Conflicted safety panel let Vioxx study continue, https://www.npr.org/templates/story/story.php?storyId=5462419 2006 (Accessed 8 January 2018).

Echt DS Liebson PR Mitchell LB et al . Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991; 324: 781–788.

Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med 1989; 321: 406–412.

https://www.npr.org/templates/story/story.php?storyId=5462419 2006: (Accessed 6 February 2018).

Caplan A. Enhancing patient autonomy through peer review to replace the FDA’s rigorous approval process. Health Aff 2012; 31: 2236–2240.

Zhang Q Freidlin B Korn EL et al . Comparison of futility monitoring guidelines using completed phase III oncology trials. Clin Trials 2017; 14: 48–58.

DeMets DL Ellenberg SS. Data monitoring committees—expect the unexpected. N Engl J Med 2016; 375: 1365–1371.

https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-data-and-safety-monitoring-extramural-clinical-studies 2014 (Accessed 29 May 2018).

https://www.ctti-clinicaltrials.org/projects/data-monitoring-committees-dmcs 2018 (Accessed 16 January 2018)