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The independent statistician for data monitoring committees.
DeMets DL, Fleming TR. DeMets DL, et al. Stat Med. 2004 May 30;23(10):1513-7. doi: 10.1002/sim.1786. Stat Med. 2004. PMID: 15122729
Issues in using progression-free survival when evaluating oncology products.
Fleming TR, Rothmann MD, Lu HL. Fleming TR, et al. J Clin Oncol. 2009 Jun 10;27(17):2874-80. doi: 10.1200/JCO.2008.20.4107. Epub 2009 May 4. J Clin Oncol. 2009. PMID: 19414672 Free PMC article.
Biomarkers and surrogate endpoints in clinical trials.
Fleming TR, Powers JH. Fleming TR, et al. Stat Med. 2012 Nov 10;31(25):2973-84. doi: 10.1002/sim.5403. Epub 2012 Jun 18. Stat Med. 2012. PMID: 22711298 Free PMC article.
Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability.
DeMets DL, Fleming TR, Geller G, Ransohoff DF. DeMets DL, et al. Sci Eng Ethics. 2017 Aug;23(4):1199-1205. doi: 10.1007/s11948-016-9844-4. Epub 2016 Nov 23. Sci Eng Ethics. 2017. PMID: 27882502
Data Monitoring Committees: Current issues.
Fleming TR, Ellenberg SS, DeMets DL. Fleming TR, et al. Clin Trials. 2018 Aug;15(4):321-328. doi: 10.1177/1740774518764855. Epub 2018 Apr 9. Clin Trials. 2018. PMID: 29629815 Free PMC article.
Protecting the confidentiality of interim data: addressing current challenges.
Fleming TR. Fleming TR. Clin Trials. 2015 Feb;12(1):5-11. doi: 10.1177/1740774514561243. Epub 2014 Dec 4. Clin Trials. 2015. PMID: 25475877 Free PMC article.
Addressing missing data in clinical trials.
Fleming TR. Fleming TR. Ann Intern Med. 2011 Jan 18;154(2):113-7. doi: 10.7326/0003-4819-154-2-201101180-00010. Ann Intern Med. 2011. PMID: 21242367 Free PMC article.
Liability issues for data monitoring committee members.
DeMets DL, Fleming TR, Rockhold F, Massie B, Merchant T, Meisel A, Mishkin B, Wittes J, Stump D, Califf R. DeMets DL, et al. Clin Trials. 2004;1(6):525-31. doi: 10.1191/1740774504cn54oa. Clin Trials. 2004. PMID: 16279293
Some design issues in trials of microbicides for the prevention of HIV infection.
Fleming TR, Richardson BA. Fleming TR, et al. J Infect Dis. 2004 Aug 15;190(4):666-74. doi: 10.1086/422603. Epub 2004 Jul 20. J Infect Dis. 2004. PMID: 15272392
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