Abstract
Get full access to this article
View all access options for this article.
References
1.
Nissen
S
. Commentary: confidentiality of interim trial data: the emerging crisis . Clin Trials 2015 ; 12 : 15 –17 .
2.
London
AJ
. Commentary: data monitoring confidentiality and FDA transparency . Clin Trials 2015 ; 12 : 12 –14 .
3.
Chuang-Stein
C
Jiang
Q
Marchenko
O
. Commentary: preserving confidentiality of interim data . Clin Trials 2015 ; 12 : 18 –20 .
4.
US Code of Federal Regulations FDA Subpart H 21 CFR, Secs. 314.500–314.560, http://cfr.regstoday.com/21cfr314.aspx#21_CFR_SUBPART_H (accessed 27 November 2014 ).
5.Food and Drug Administration . Guidance for industry. Diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes , http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf
6.
Ellenberg
S
Fleming
T
DeMets
D
. Data monitoring committees in clinical trials: a practical perspective . West Sussex : John Wiley & Sons, Ltd , 2002 .
7.
Fleming
TR
. Protecting the confidentiality of interim data: addressing current challenges . Clin Trials 2015 ; 12 : 5 –11 .
8.
Fleming
TR
. Clinical trials: discerning hype from substance . Ann Intern Med 2010 ; 153 : 400 –406 .