-
1
-
-
0023874973
-
Organization, review, and administration of cooperative studies (Greenberg Report): A report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967
-
Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. Contemp Clin Trials 1988; 9: 137-148.
-
(1988)
Contemp Clin Trials
, vol.9
, pp. 137-148
-
-
-
2
-
-
0019564664
-
Practical aspects of decision making in clinical trials: The Coronary Drug Project as a case study
-
Practical aspects of decision making in clinical trials: the Coronary Drug Project as a case study. Control Clin Trials 1981; 1: 363-376.
-
(1981)
Control Clin Trials
, vol.1
, pp. 363-376
-
-
-
4
-
-
33744813860
-
Issues in regulatory guidelines for data monitoring committees
-
DeMets D, Califf R, Dixon D, et al. Issues in regulatory guidelines for data monitoring committees. Clin Trials 2004; 1: 162-169.
-
(2004)
Clin Trials
, vol.1
, pp. 162-169
-
-
Demets, D.1
Califf, R.2
Dixon, D.3
-
7
-
-
0035092538
-
The role of an independent statistical analysis center in the industry-modified National Institutes of Health model
-
Fisher MR, Roecker EB, DeMets DL., The role of an independent statistical analysis center in the industry-modified National Institutes of Health model. Drug Inf J 2001; 35: 115-129.
-
(2001)
Drug Inf J
, vol.35
, pp. 115-129
-
-
Fisher, M.R.1
Roecker, E.B.2
Demets, D.L.3
-
9
-
-
34548616370
-
Monitoring the randomized trials of the Women's Health Initiative: The experience of the Data and Safety Monitoring Board
-
Wittes J, Barrett-Connor E, Braunwald E, et al. 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.
-
(2007)
Clin Trials
, vol.4
, pp. 218-234
-
-
Wittes, J.1
Barrett-Connor, E.2
Braunwald, E.3
-
10
-
-
36849062291
-
Monitoring the ACTIVE-W trial: Some issues in monitoring a noninferiority trial
-
Cairns JA, Wittes J, Wyse DG, et al. Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial. Am Heart J 2008; 155: 33-41.
-
(2008)
Am Heart J
, vol.155
, pp. 33-41
-
-
Cairns, J.A.1
Wittes, J.2
Wyse, D.G.3
-
11
-
-
8444244421
-
The data monitoring experience in the MOXCON trial
-
Pocock S, Wilhelmsen L, Dickstein K, et al. The data monitoring experience in the MOXCON trial. Eur Heart J 2004; 25: 1974-1978.
-
(2004)
Eur Heart J
, vol.25
, pp. 1974-1978
-
-
Pocock, S.1
Wilhelmsen, L.2
Dickstein, K.3
-
12
-
-
85017129337
-
-
UW Institute for Clinical and Translational Research Web site, (accessed 9 February 2017)
-
DeMets D, Neaton J,. Online video for training DMC members. UW Institute for Clinical and Translational Research Web site, https://redcap.ictr.wisc.edu/surveys/?s=rke49fSLfu (2016,. accessed 9 February 2017).
-
(2016)
Online Video for Training DMC Members
-
-
Demets, D.1
Neaton, J.2
-
14
-
-
84898924137
-
The landscape of clinical trials in nephrology: A systematic review of Clinicaltrials.gov
-
Inrig JK, Califf RM, Tasneem A, et al. The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov. Am J Kidney Dis 2014; 63: 771-780.
-
(2014)
Am J Kidney Dis
, vol.63
, pp. 771-780
-
-
Inrig, J.K.1
Califf, R.M.2
Tasneem, A.3
-
15
-
-
4544274355
-
Reported use of data monitoring committees in the main published reports of randomized controlled trials: A cross-sectional study
-
Sydes MR, Altman DG, Babiker AB, et al. Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study. Clin Trials 2004; 1: 48-59.
-
(2004)
Clin Trials
, vol.1
, pp. 48-59
-
-
Sydes, M.R.1
Altman, D.G.2
Babiker, A.B.3
-
16
-
-
84860444921
-
Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010
-
Califf RM, Zarin DA, Kramer JM, et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 2012; 307: 1838-1847.
-
(2012)
JAMA
, vol.307
, pp. 1838-1847
-
-
Califf, R.M.1
Zarin, D.A.2
Kramer, J.M.3
-
17
-
-
85017094175
-
-
CTTIData Monitoring Committees Project Expert Meeting: 28-29, (accessed 8 February 2016)
-
CTTIData Monitoring Committees Project Expert Meeting: 28-29 2015, https://www.ctti-clinicaltrials.org/briefing-room/meetings/ctti-data-monitoring-committees-project-expert-meeting (. accessed 8 February 2016).
-
(2015)
-
-
-
18
-
-
0038369246
-
Toward protecting the safety of participants in clinical trials
-
Califf RM, Morse MA, Wittes J, et al. Toward protecting the safety of participants in clinical trials. Control Clin Trials 2003; 24: 256-271.
-
(2003)
Control Clin Trials
, vol.24
, pp. 256-271
-
-
Califf, R.M.1
Morse, M.A.2
Wittes, J.3
-
19
-
-
84905095178
-
Independent data monitoring committees: Preparing a path for the future
-
Hess CN, Roe MT, Gibson CM, et al. Independent data monitoring committees: preparing a path for the future. Am Heart J 2014; 168: 135-141.
-
(2014)
Am Heart J
, vol.168
, pp. 135-141
-
-
Hess, C.N.1
Roe, M.T.2
Gibson, C.M.3
-
20
-
-
33746242241
-
Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees
-
Dixon DO, Freedman RS, Herson J, et al. Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees. Clin Trials 2006; 3: 314-319.
-
(2006)
Clin Trials
, vol.3
, pp. 314-319
-
-
Dixon, D.O.1
Freedman, R.S.2
Herson, J.3
-
21
-
-
84905986814
-
Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials
-
Fleming TR, Hennekens CH, Pfeffer MA, et al. Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials. J Biopharm Stat 2014; 24: 968-975.
-
(2014)
J Biopharm Stat
, vol.24
, pp. 968-975
-
-
Fleming, T.R.1
Hennekens, C.H.2
Pfeffer, M.A.3
-
22
-
-
85017181634
-
-
Clinical & Translational Science Awards. About the CTSA Consortium, (accessed 8 February 2016)
-
Clinical & Translational Science Awards. About the CTSA Consortium, https://ctsacentral.org/about-us/ctsa/ (. accessed 8 February 2016).
-
-
-
-
23
-
-
84983802145
-
Responsibilities of data monitoring committees: Consensus recommendations
-
Epub ahead of print 13 May 2016. DOI: 10.1177/2168479016646812
-
Bierer BE, Li R, Seltzer J, et al. Responsibilities of data monitoring committees: consensus recommendations. Ther Innov Regul Sci. Epub ahead of print 13 May 2016. DOI: 10.1177/2168479016646812.
-
Ther Innov Regul Sci
-
-
Bierer, B.E.1
Li, R.2
Seltzer, J.3
-
24
-
-
79551622288
-
Addressing missing data in clinical trials
-
Fleming TR., Addressing missing data in clinical trials. Ann Intern Med 2011; 54: 113-117.
-
(2011)
Ann Intern Med
, vol.54
, pp. 113-117
-
-
Fleming, T.R.1
-
25
-
-
75749093972
-
Data and safety monitoring boards: Legal and ethical considerations for research accountability
-
Tereskerz PM., Data and safety monitoring boards: legal and ethical considerations for research accountability. Account Res 2010; 17: 30-50.
-
(2010)
Account Res
, vol.17
, pp. 30-50
-
-
Tereskerz, P.M.1
-
26
-
-
33644618943
-
Liability issues for data monitoring committee members
-
DeMets DL, Fleming TR, Rockhold F, et al. Liability issues for data monitoring committee members. Clin Trials 2004; 1: 525-531.
-
(2004)
Clin Trials
, vol.1
, pp. 525-531
-
-
Demets, D.L.1
Fleming, T.R.2
Rockhold, F.3
-
27
-
-
84922374669
-
Protecting the confidentiality of interim data: Addressing current challenges
-
Fleming TR., Protecting the confidentiality of interim data: addressing current challenges. Clin Trials 2015; 12: 5-11.
-
(2015)
Clin Trials
, vol.12
, pp. 5-11
-
-
Fleming, T.R.1
-
28
-
-
43649105816
-
Maintaining confidentiality of interim data to enhance trial integrity and credibility
-
Fleming TR, Sharples K, McCall J, et al. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials 2008; 5: 157-167.
-
(2008)
Clin Trials
, vol.5
, pp. 157-167
-
-
Fleming, T.R.1
Sharples, K.2
McCall, J.3
-
29
-
-
84960336623
-
On independent data monitoring committees in oncology clinical trials
-
Wittes J, Schactman M., On independent data monitoring committees in oncology clinical trials. Chin Clin Oncol 2014; 3: 40.
-
(2014)
Chin Clin Oncol
, vol.3
, pp. 40
-
-
Wittes, J.1
Schactman, M.2
-
30
-
-
83455162665
-
What information should a sponsor of a randomized trial receive during its conduct?
-
Anand SS, Wittes J, Yusuf S., What information should a sponsor of a randomized trial receive during its conduct? Clin Trials 2011; 8: 716-719.
-
(2011)
Clin Trials
, vol.8
, pp. 716-719
-
-
Anand, S.S.1
Wittes, J.2
Yusuf, S.3
-
31
-
-
84960918373
-
Effect of Naltrexone-Bupropion on major adverse cardiovascular events in overweight and obese patients with cardiovascular risk factors: A randomized clinical trial
-
Nissen SE, Wolski KE, Prcela L, et al. Effect of Naltrexone-Bupropion on major adverse cardiovascular events in overweight and obese patients with cardiovascular risk factors: a randomized clinical trial. JAMA 2016; 315: 990-1004.
-
(2016)
JAMA
, vol.315
, pp. 990-1004
-
-
Nissen, S.E.1
Wolski, K.E.2
Prcela, L.3
-
33
-
-
0027537733
-
Panel discussion: The operation of data monitoring committees
-
Yusuf S, Whitley DR, Ascenzo R, et al. Panel discussion: the operation of data monitoring committees. Stat Med 1993; 12: 527-542.
-
(1993)
Stat Med
, vol.12
, pp. 527-542
-
-
Yusuf, S.1
Whitley, D.R.2
Ascenzo, R.3
-
34
-
-
0032493079
-
Masked monitoring in clinical trials-blind stupidity?
-
Meinert CL., Masked monitoring in clinical trials-blind stupidity? N Engl J Med 1998; 338: 1381-1382.
-
(1998)
N Engl J Med
, vol.338
, pp. 1381-1382
-
-
Meinert, C.L.1
-
36
-
-
0029591767
-
The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials
-
DeMets DL, Ellenberg S, Fleming TR, et al. The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. Control Clin Trials 1995; 16: 408-412.
-
(1995)
Control Clin Trials
, vol.16
, pp. 408-412
-
-
Demets, D.L.1
Ellenberg, S.2
Fleming, T.R.3
-
37
-
-
84863475669
-
On the independence of data monitoring committee in adaptive design clinical trials
-
Chow SC, Corey R, Lin M., On the independence of data monitoring committee in adaptive design clinical trials. J Biopharm Stat 2012; 22: 853-867.
-
(2012)
J Biopharm Stat
, vol.22
, pp. 853-867
-
-
Chow, S.C.1
Corey, R.2
Lin, M.3
-
38
-
-
2442667708
-
The independent statistician for data monitoring committees
-
DeMets DL, Fleming TR., The independent statistician for data monitoring committees. Stat Med 2004; 23: 1513-1517.
-
(2004)
Stat Med
, vol.23
, pp. 1513-1517
-
-
Demets, D.L.1
Fleming, T.R.2
-
39
-
-
85017104140
-
-
University of Wisconsin-Madison Statistical Data Analysis Center. Sample closed session DMC Report, 15, (accessed 8 February 2016)
-
University of Wisconsin-Madison Statistical Data Analysis Center. Sample closed session DMC Report, 15 2014, https://www.biostat.wisc.edu/sites/default/files/sample-report-closed-2.pdf (. accessed 8 February 2016).
-
(2014)
-
-
-
40
-
-
84864651857
-
Protecting clinical trial integrity and protecting data integrity: Are we meeting the challenges?
-
Ellenberg SS., Protecting clinical trial integrity and protecting data integrity: are we meeting the challenges? PLoS Med 2012; 9: e1001234.
-
(2012)
PLoS Med
, vol.9
, pp. e1001234
-
-
Ellenberg, S.S.1
-
41
-
-
77955061588
-
Don't mess with the DSMB
-
Drazen JM, Wood AJ., Don't mess with the DSMB. N Engl J Med 2010; 363: 477-478.
-
(2010)
N Engl J Med
, vol.363
, pp. 477-478
-
-
Drazen, J.M.1
Wood, A.J.2
-
42
-
-
25844468887
-
-
European Medicines Agency. Guideline on Data Monitoring Committees, 2005 (2005, accessed 16 June 2016)
-
European Medicines Agency. Committee for medicinal products for human use. Guideline on Data Monitoring Committees, 2005 http://osp.od.nih.gov/sites/default/files/resources/WC500003635.pdf (. 2005, accessed 16 June 2016).
-
Committee for Medicinal Products for Human Use
-
-
-
43
-
-
85017123218
-
-
Pharmaceuticals and Medical Devices Agency. Guideline on Data Monitoring Committees (PFSB/ELD notification 0404-1) issued in Japanese on 4, (accessed 16 June 2016)
-
Pharmaceuticals and Medical Devices Agency. Guideline on Data Monitoring Committees (PFSB/ELD notification No. 0404-1) issued in Japanese on 4 2013, https://www.pmda.go.jp/files/000204620.pdf (. accessed 16 June 2016).
-
(2013)
-
-
-
44
-
-
84918772240
-
Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents
-
Kereiakes DJ, Yeh RW, Driscoll-Shempp P, et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014; 371: 2155-2166.
-
(2014)
N Engl J Med
, vol.371
, pp. 2155-2166
-
-
Kereiakes, D.J.1
Yeh, R.W.2
Driscoll-Shempp, P.3
|