-
1
-
-
0023874973
-
Organization, review and administration of cooperative studies: a report from the Heart Special Projects Committee to the National Advisory Heart Council, May 1967
-
Heart Special Project Committee
-
Heart Special Project Committee (1988) Organization, review and administration of cooperative studies: a report from the Heart Special Projects Committee to the National Advisory Heart Council, May 1967. Control Clin Trials 9: 137-148.
-
(1988)
Control Clin Trials
, vol.9
, pp. 137-148
-
-
-
2
-
-
0017744944
-
Group sequential methods in the design and analysis of clinical trials
-
Pocock SJ, (1977) Group sequential methods in the design and analysis of clinical trials. Biometrika 64: 191-199.
-
(1977)
Biometrika
, vol.64
, pp. 191-199
-
-
Pocock, S.J.1
-
3
-
-
0018687930
-
A multiple testing procedure for clinical trials
-
O'Brien PC, Fleming TR, (1979) A multiple testing procedure for clinical trials. Biometrics 35: 549-556.
-
(1979)
Biometrics
, vol.35
, pp. 549-556
-
-
O'Brien, P.C.1
Fleming, T.R.2
-
4
-
-
70449529019
-
Discrete sequential boundaries for clinical trials
-
Lan KKG, DeMets DL, (1983) Discrete sequential boundaries for clinical trials. Biometrika 70: 659-663.
-
(1983)
Biometrika
, vol.70
, pp. 659-663
-
-
Lan, K.K.G.1
DeMets, D.L.2
-
6
-
-
0027566177
-
Proceedings of Practical Issues in Data Monitoring of Clinical Trials
-
Ellenberg SS, Geller N, Simon R, Yusuf S, eds. (1993) Proceedings of "Practical Issues in Data Monitoring of Clinical Trials." Stat Med 12: 415-616.
-
(1993)
Stat Med
, vol.12
, pp. 415-616
-
-
Ellenberg, S.S.1
Geller, N.2
Simon, R.3
Yusuf, S.4
-
10
-
-
0003770817
-
NIH policy for data and safety monitoring
-
National Institutes of Health, Available:. Accessed 15 October 2011
-
National Institutes of Health (1998) NIH policy for data and safety monitoring. Available: http://grants.nih.gov/grants/guide/notice-files/not98-084.html. Accessed 15 October 2011.
-
(1998)
-
-
-
11
-
-
34748860155
-
Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees
-
Food and Drug Administration, Available:. Accessed 15 October 2011
-
Food and Drug Administration (2006) Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees. Available: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf. Accessed 15 October 2011.
-
(2006)
-
-
-
12
-
-
33745128497
-
Guideline on data monitoring committees
-
European Medicines Agency Committee for Medicinal Products for Human Use, Available:. Accessed 15 October 2011
-
European Medicines Agency Committee for Medicinal Products for Human Use (2005) Guideline on data monitoring committees. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003635.pdf. Accessed 15 October 2011.
-
(2005)
-
-
-
13
-
-
33845636958
-
Operational guidelines for the establishment and functioning of data and safety monitoring boards
-
World Health Organization, Available:. Accessed 15 October 2011
-
World Health Organization (2005) Operational guidelines for the establishment and functioning of data and safety monitoring boards. Available: http://whqlibdoc.who.int/hq/2005/TDR_GEN_Guidelines_05.1_eng.pdf. Accessed 15 October 2011.
-
(2005)
-
-
-
14
-
-
34548616839
-
Issues in data monitoring and interim analysis of trials (the DAMOCLES study)
-
Grant AM, Sydes M, McLeer S, Clemens F, Altman DG, et al. (2005) Issues in data monitoring and interim analysis of trials (the DAMOCLES study). Health Technology Assess 9: 1-238.
-
(2005)
Health Technology Assess
, vol.9
, pp. 1-238
-
-
Grant, A.M.1
Sydes, M.2
McLeer, S.3
Clemens, F.4
Altman, D.G.5
-
15
-
-
4544333778
-
Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials
-
Sydes MR, Spiegelhalter DJ, Altman DG, Babiker AB, Parmar MK, et al. (2004) Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials 1: 60-79.
-
(2004)
Clin Trials
, vol.1
, pp. 60-79
-
-
Sydes, M.R.1
Spiegelhalter, D.J.2
Altman, D.G.3
Babiker, A.B.4
Parmar, M.K.5
-
16
-
-
4544274355
-
Reported use of data monitoring committees in the main published reports of randomized controlled trials
-
Sydes MR, Altman DG, Babiker AB, Parmar AK, Spiegelhalter DJ, et al. (2004) Reported use of data monitoring committees in the main published reports of randomized controlled trials. Clin Trials 1: 48-59.
-
(2004)
Clin Trials
, vol.1
, pp. 48-59
-
-
Sydes, M.R.1
Altman, D.G.2
Babiker, A.B.3
Parmar, A.K.4
Spiegelhalter, D.J.5
-
17
-
-
85044116279
-
Vioxx and the Merck team effort. The Kenan Institute for Ethics at Duke University
-
Available:. Accessed 15 October 2011
-
Presley H., Vioxx and the Merck team effort. The Kenan Institute for Ethics at Duke University. Available: http://www.duke.edu/web/kenanethics/CaseStudies/Vioxx.pdf. Accessed 15 October 2011.
-
-
-
Presley, H.1
-
18
-
-
77955061588
-
Don't mess with the DSMB
-
Drazen JM, Wood AJJ, (2010) Don't mess with the DSMB. N Eng J Med 363: 477-478.
-
(2010)
N Eng J Med
, vol.363
, pp. 477-478
-
-
Drazen, J.M.1
Wood, A.J.J.2
-
19
-
-
77958525396
-
The paradoxical problem with multiple-IRB review
-
Menikoff J, (2010) The paradoxical problem with multiple-IRB review. N Eng J Med 363: 1591-1593.
-
(2010)
N Eng J Med
, vol.363
, pp. 1591-1593
-
-
Menikoff, J.1
-
20
-
-
79959474987
-
How local IRBs view central IRBs in the US
-
Accessed 20 April 2012
-
Klitzman R, (2011) How local IRBs view central IRBs in the US. BMC Medical Ethics 12: 13 http://www.biomedcentral.com/1472-6939/12/13. Accessed 20 April 2012.
-
(2011)
BMC Medical Ethics
, vol.12
, pp. 13
-
-
Klitzman, R.1
-
21
-
-
34548616370
-
Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board
-
Wittes J, Barrett-Conner E, Braunwald E, Chesney M, Cohen HJ, et al. (2007) Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials 4: 218-234.
-
(2007)
Clin Trials
, vol.4
, pp. 218-234
-
-
Wittes, J.1
Barrett-Conner, E.2
Braunwald, E.3
Chesney, M.4
Cohen, H.J.5
-
22
-
-
68149141131
-
Data safety monitoring boards: a word from a sponsor (NHLBI)
-
Mondero TH, (2009) Data safety monitoring boards: a word from a sponsor (NHLBI). Transfusion 49: 1537-1539.
-
(2009)
Transfusion
, vol.49
, pp. 1537-1539
-
-
Mondero, T.H.1
-
23
-
-
83455169023
-
Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials
-
Dixon DO, Weiss S, Cahill K, Fox L, Love J, et al. (2011) Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials. Clin Trials 8: 727-735.
-
(2011)
Clin Trials
, vol.8
, pp. 727-735
-
-
Dixon, D.O.1
Weiss, S.2
Cahill, K.3
Fox, L.4
Love, J.5
-
24
-
-
84864683388
-
NHLBI policy for data and safety monitoring of extramural clinical studies
-
National Heart, Lung, and Blood Institute, Available:. Accessed 20 April 2012
-
National Heart, Lung, and Blood Institute (October 2011) NHLBI policy for data and safety monitoring of extramural clinical studies. Available: http://www.nhlbi.nih.gov/funding/policies/dsmpolicy.htm. Accessed 20 April 2012.
-
(2011)
-
-
-
25
-
-
2442667708
-
The independent statistician for data monitoring committees
-
DeMets DL, Fleming TR, (2004) The independent statistician for data monitoring committees. Stat Med 23: 1513-1517.
-
(2004)
Stat Med
, vol.23
, pp. 1513-1517
-
-
DeMets, D.L.1
Fleming, T.R.2
-
26
-
-
2442687883
-
Independence of the statistician who analyses unblinded data
-
Siegel JP, O'Neill RT, Temple R, Campbell G, Foulkes MA, (2004) Independence of the statistician who analyses unblinded data. Stat Med 23: 1527-1529.
-
(2004)
Stat Med
, vol.23
, pp. 1527-1529
-
-
Siegel, J.P.1
O'Neill, R.T.2
Temple, R.3
Campbell, G.4
Foulkes, M.A.5
-
27
-
-
2442643951
-
A major trial needs three statisticians: why, how and who?
-
Pocock SJ, (2004) A major trial needs three statisticians: why, how and who? Stat Med 23: 1535-1539.
-
(2004)
Stat Med
, vol.23
, pp. 1535-1539
-
-
Pocock, S.J.1
-
28
-
-
2442686637
-
Should statisticians reporting to a data monitoring committee be independent of the trial sponsor and leadership?
-
Ellenberg SS, George SL, (2004) Should statisticians reporting to a data monitoring committee be independent of the trial sponsor and leadership? Stat Med 23: 1503-1505.
-
(2004)
Stat Med
, vol.23
, pp. 1503-1505
-
-
Ellenberg, S.S.1
George, S.L.2
-
29
-
-
2442715089
-
Playing safe and preserving integrity: making the FDA model work
-
Wittes J, (2004) Playing safe and preserving integrity: making the FDA model work. Stat Med 23: 1523-1525.
-
(2004)
Stat Med
, vol.23
, pp. 1523-1525
-
-
Wittes, J.1
-
30
-
-
0016403659
-
Statistics: the problem of examining accumulating data more than once
-
McPherson K, (1974) Statistics: the problem of examining accumulating data more than once. N Engl J Med 290: 501-502.
-
(1974)
N Engl J Med
, vol.290
, pp. 501-502
-
-
McPherson, K.1
-
31
-
-
0026660156
-
When to stop a clinical trial
-
Pocock SJ, (1992) When to stop a clinical trial. BMJ 305: 235-240.
-
(1992)
BMJ
, vol.305
, pp. 235-240
-
-
Pocock, S.J.1
-
32
-
-
84864713776
-
Proceedings of Practical Issues in Data Monitoring of Clinical Trials
-
Ellenberg S, Geller N, Simon R, Yusuf S, eds. Proceedings of "Practical Issues in Data Monitoring of Clinical Trials." Stat Med 12: 521-525.
-
Stat Med
, vol.12
, pp. 521-525
-
-
Ellenberg, S.1
Geller, N.2
Simon, R.3
Yusuf, S.4
-
33
-
-
38349177944
-
Early stopping of randomized clinical trials for overt efficacy is problematic
-
Bassler D, Montori V, Briel M, Glasziou P, Guyatt G, (2008) Early stopping of randomized clinical trials for overt efficacy is problematic. J Clin Epid 61: 241-246.
-
(2008)
J Clin Epid
, vol.61
, pp. 241-246
-
-
Bassler, D.1
Montori, V.2
Briel, M.3
Glasziou, P.4
Guyatt, G.5
-
34
-
-
77949879943
-
Stopping randomized trials early for benefit and estimation of treatment effects
-
Bassler D, Briel M, Montori VM, Lane M, Glasziou P, et al. (2010) Stopping randomized trials early for benefit and estimation of treatment effects. JAMA 303: 1180-1187.
-
(2010)
JAMA
, vol.303
, pp. 1180-1187
-
-
Bassler, D.1
Briel, M.2
Montori, V.M.3
Lane, M.4
Glasziou, P.5
-
35
-
-
77954573051
-
Bias and trials stopped early for benefit (letter)
-
Berry SM, Carlin BP, Connor J, (2010) Bias and trials stopped early for benefit (letter). JAMA 304: 156.
-
(2010)
JAMA
, vol.304
, pp. 156
-
-
Berry, S.M.1
Carlin, B.P.2
Connor, J.3
-
36
-
-
77954586754
-
Bias and trials stopped early for benefit (letter)
-
Goodman S, Berry D, Wittes J, (2010) Bias and trials stopped early for benefit (letter). JAMA 304: 157.
-
(2010)
JAMA
, vol.304
, pp. 157
-
-
Goodman, S.1
Berry, D.2
Wittes, J.3
-
37
-
-
77954586754
-
Bias and trials stopped early for benefit (letter)
-
Korn EL, Friedlin B, Mooney M, (2010) Bias and trials stopped early for benefit (letter). JAMA 304: 157-158.
-
(2010)
JAMA
, vol.304
, pp. 157-158
-
-
Korn, E.L.1
Friedlin, B.2
Mooney, M.3
-
38
-
-
77954580305
-
Bias and trials stopped early for benefit (letter)
-
Ellenberg SS, DeMets DL, Fleming TR, (2010) Bias and trials stopped early for benefit (letter). JAMA 304: 158.
-
(2010)
JAMA
, vol.304
, pp. 158
-
-
Ellenberg, S.S.1
DeMets, D.L.2
Fleming, T.R.3
-
39
-
-
0037306203
-
Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML 12 randomization
-
Wheatley K, Clayton D, (2003) Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML 12 randomization. Control Clin Trials 24: 66-70.
-
(2003)
Control Clin Trials
, vol.24
, pp. 66-70
-
-
Wheatley, K.1
Clayton, D.2
-
40
-
-
33644618943
-
Liability issues for data monitoring committee members
-
DeMets DL, Fleming TR, Rockhold F, Massie B, Merchant T, et al. (2004) Liability issues for data monitoring committee members. Clin Trials 1: 525-531.
-
(2004)
Clin Trials
, vol.1
, pp. 525-531
-
-
DeMets, D.L.1
Fleming, T.R.2
Rockhold, F.3
Massie, B.4
Merchant, T.5
-
41
-
-
75749093972
-
Data safety monitoring boards: legal and ethical considerations for research accountability
-
Tereskerz PM, (2010) Data safety monitoring boards: legal and ethical considerations for research accountability. Account Res 17: 30-50.
-
(2010)
Account Res
, vol.17
, pp. 30-50
-
-
Tereskerz, P.M.1
|