Rejoinder

Affiliations

¹ 1 Department of Biostatistics, University of Washington, Seattle, WA, USA.
² 2 University of Wisconsin, Madison, WI, USA.
³ 3 Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
⁴ 4 Statistics Collaborative, Inc., Washington, DC, USA.
⁵ 5 Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
⁶ 6 National Institute of Child Health and Human Development, National Institutes of Health (NIH), Bethesda, MD, USA.
⁷ 7 University of Pittsburgh, Pittsburgh, PA, USA.
⁸ 8 Merck Research Laboratories, North Wales, PA, USA.
⁹ 9 Tufts Medical Center, Boston, MA, USA.
¹⁰ 10 National Heart, Lung and Blood Institute, National Institutes of Health (NIH), Bethesda, MD, USA.
¹¹ 11 Stanford University School of Medicine, Stanford, CA, USA.
¹² 12 Florida Atlantic University, Boca Raton, FL, USA.
¹³ 13 University of Minnesota, Minneapolis, MN, USA.
¹⁴ 14 AstraZeneca, Mölndal, Sweden.
¹⁵ 15 Brigham and Women's Hospital, Boston, MA, USA.
¹⁶ 16 University of Pennsylvania, Philadelphia, PA, USA.

Comment

Thomas R Fleming et al. Clin Trials. 2017 Apr.

. 2017 Apr;14(2):126-127.

doi: 10.1177/1740774516688917. Epub 2017 Jan 31.

¹ 1 Department of Biostatistics, University of Washington, Seattle, WA, USA.
² 2 University of Wisconsin, Madison, WI, USA.
³ 3 Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
⁴ 4 Statistics Collaborative, Inc., Washington, DC, USA.
⁵ 5 Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
⁶ 6 National Institute of Child Health and Human Development, National Institutes of Health (NIH), Bethesda, MD, USA.
⁷ 7 University of Pittsburgh, Pittsburgh, PA, USA.
⁸ 8 Merck Research Laboratories, North Wales, PA, USA.
⁹ 9 Tufts Medical Center, Boston, MA, USA.
¹⁰ 10 National Heart, Lung and Blood Institute, National Institutes of Health (NIH), Bethesda, MD, USA.
¹¹ 11 Stanford University School of Medicine, Stanford, CA, USA.
¹² 12 Florida Atlantic University, Boca Raton, FL, USA.
¹³ 13 University of Minnesota, Minneapolis, MN, USA.
¹⁴ 14 AstraZeneca, Mölndal, Sweden.
¹⁵ 15 Brigham and Women's Hospital, Boston, MA, USA.
¹⁶ 16 University of Pennsylvania, Philadelphia, PA, USA.

No abstract available

Comment on

Commentary on Fleming et al.: Data monitoring committee evidence base needed.
Terrin M. Terrin M. Clin Trials. 2017 Apr;14(2):124-125. doi: 10.1177/1740774516688916. Epub 2017 Jan 31. Clin Trials. 2017. PMID: 28142249 No abstract available.
Data monitoring committees: Promoting best practices to address emerging challenges.
Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN, Meisel A, Bain RP, Konstam MA, Pencina MJ, Gordon DJ, Mahaffey KW, Hennekens CH, Neaton JD, Pearson GD, Andersson TL, Pfeffer MA, Ellenberg SS. Fleming TR, et al. Clin Trials. 2017 Apr;14(2):115-123. doi: 10.1177/1740774516688915. Epub 2017 Feb 1. Clin Trials. 2017. PMID: 28359194 Free PMC article.

1. Terrin M. Commentary on Fleming et al.: Data monitoring committee evidence base needed. Clin Trials. in press. - PubMed
1. Calis KA, Archdeacon P, Bain RP, et al. Understanding the functions and operations of data monitoring committees: Survey and focus group findings. Clin Trials. Epub ahead of print 24 November 2016. - PubMed