-
2
-
-
0023491186
-
Treatment evaluation in active control studies
-
Fleming TR. Treatment evaluation in active control studies. Cancer Treatment Reports 1987; 71:1061-1064.
-
(1987)
Cancer Treatment Reports
, vol.71
, pp. 1061-1064
-
-
Fleming, T.R.1
-
3
-
-
0002455270
-
Active control equivalence studies: Do they address the efficacy issue?
-
Marcel Dekker: New York
-
Pledger G, Hall DB. Active control equivalence studies: do they address the efficacy issue? In Statistical Issues in Drug Research and Development. Marcel Dekker: New York, 1990; 226-238.
-
(1990)
Statistical Issues in Drug Research and Development
, pp. 226-238
-
-
Pledger, G.1
Hall, D.B.2
-
5
-
-
0030367916
-
Problems in interpreting active control equivalence trials
-
Temple R. Problems in interpreting active control equivalence trials. Accountability in Research 1996; 4: 267-275.
-
(1996)
Accountability in Research
, vol.4
, pp. 267-275
-
-
Temple, R.1
-
6
-
-
0032528867
-
Practical issues in equivalence trials
-
Ebbutt AF, Frith L. Practical issues in equivalence trials. Statistics in Medicine 1998; 17:1691-1701.
-
(1998)
Statistics in Medicine
, vol.17
, pp. 1691-1701
-
-
Ebbutt, A.F.1
Frith, L.2
-
7
-
-
0032529072
-
Therapeutic equivalence investigations: Statistical considerations
-
Rohmel J. Therapeutic equivalence investigations: statistical considerations. Statistics in Medicine 1998; 17:1703-1714.
-
(1998)
Statistics in Medicine
, vol.17
, pp. 1703-1714
-
-
Rohmel, J.1
-
9
-
-
0034038179
-
Equivalence and noninferiority trials
-
Siegel JP. Equivalence and noninferiority trials. American Heart Journal 2000; 139:S166-S170.
-
(2000)
American Heart Journal
, vol.139
-
-
Siegel, J.P.1
-
10
-
-
0034038181
-
Design and interpretation of equivalence trials
-
Fleming TR. Design and interpretation of equivalence trials. American Heart Journal 2000; 139:S171-S176.
-
(2000)
American Heart Journal
, vol.139
-
-
Fleming, T.R.1
-
11
-
-
0034687072
-
Placebo-controlled trials and active-control trials in the evaluation of new treatments - Part 1: Ethical and scientific issues
-
Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments - Part 1: Ethical and scientific issues. Annals of Internal Medicine 2000; 133:455-463.
-
(2000)
Annals of Internal Medicine
, vol.133
, pp. 455-463
-
-
Temple, R.1
Ellenberg, S.S.2
-
12
-
-
0034687076
-
Placebo-controlled trials and active-control trials in the evaluation of new treatments-Part 2: Practical issues and specific cases
-
Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments-Part 2: Practical issues and specific cases. Annals of Internal Medicine 2000; 133:464-470.
-
(2000)
Annals of Internal Medicine
, vol.133
, pp. 464-470
-
-
Ellenberg, S.S.1
Temple, R.2
-
13
-
-
12244249578
-
-
International Conference on Harmonization: Guidance on Choice of Control Group and Related Design and Conduct Issues in Clinical Trials (ICH E-10). Food and Drug Administration, DHHS, July
-
International Conference on Harmonization: Guidance on choice of control group and related design and conduct issues in clinical trials (ICH E-10). Food and Drug Administration, DHHS, July 2000.
-
(2000)
-
-
-
14
-
-
12244290021
-
-
CBER/FDA Memorandum. Summary of CBER considerations on selected aspects of active controlled trial design and analysis for the evaluation of thrombolytics in acute MI, June
-
CBER/FDA Memorandum. Summary of CBER considerations on selected aspects of active controlled trial design and analysis for the evaluation of thrombolytics in acute MI, June 1999.
-
(1999)
-
-
-
15
-
-
0018103242
-
Sample size requirements for evaluating a conservative therapy
-
Makuch R, Simon R. Sample size requirements for evaluating a conservative therapy. Cancer Treatment Reports 1978; 62(7):1037-1040.
-
(1978)
Cancer Treatment Reports
, vol.62
, Issue.7
, pp. 1037-1040
-
-
Makuch, R.1
Simon, R.2
-
16
-
-
0025051476
-
Planning and monitoring of equivalence studies
-
Durrleman S, Simon R. Planning and monitoring of equivalence studies. Biometrics 1990; 46(2):329-336.
-
(1990)
Biometrics
, vol.46
, Issue.2
, pp. 329-336
-
-
Durrleman, S.1
Simon, R.2
-
17
-
-
0032725063
-
Establishing equivalence by showing that a prespecified percentage of the effect of the active control over placebo is maintained
-
Holmgren EB. Establishing equivalence by showing that a prespecified percentage of the effect of the active control over placebo is maintained. Journal of Biopharmaceutical Statistics 1999; 9(4):651-659.
-
(1999)
Journal of Biopharmaceutical Statistics
, vol.9
, Issue.4
, pp. 651-659
-
-
Holmgren, E.B.1
-
18
-
-
0035173214
-
Active-control trials: How would a new agent compare with placebo? A method illustrated with clopidogrel, aspirin, and placebo
-
Fisher LD, Gent M, Büller HR. Active-control trials: How would a new agent compare with placebo? A method illustrated with clopidogrel, aspirin, and placebo. American Heart Journal 2001; 141:26-32.
-
(2001)
American Heart Journal
, vol.141
, pp. 26-32
-
-
Fisher, L.D.1
Gent, M.2
Büller, H.R.3
-
19
-
-
0035003536
-
Statistical methods for comparison to placebo in active-control trials
-
Hasselblad V, Kong DF. Statistical methods for comparison to placebo in active-control trials. Drug Information Journal 2001; 35:435-449.
-
(2001)
Drug Information Journal
, vol.35
, pp. 435-449
-
-
Hasselblad, V.1
Kong, D.F.2
-
20
-
-
0036174142
-
Utility and pitfall of some statistical methods in active controlled clinical trials
-
Wang SJ, Hung HMJ, Tsong Y. Utility and pitfall of some statistical methods in active controlled clinical trials. Controlled Clinical Trials 2002; 23(1):15-28.
-
(2002)
Controlled Clinical Trials
, vol.23
, Issue.1
, pp. 15-28
-
-
Wang, S.J.1
Hung, H.M.J.2
Tsong, Y.3
-
21
-
-
0032968433
-
Bayesian design and analysis of active control clinical trials
-
Simon R. Bayesian design and analysis of active control clinical trials. Biometrics 1999; 55:484-487.
-
(1999)
Biometrics
, vol.55
, pp. 484-487
-
-
Simon, R.1
-
23
-
-
0000785248
-
Design and analysis of group sequential tests based on the type I error spending function
-
Lan KKG, DeMets DL. Design and analysis of group sequential tests based on the type I error spending function. Biometrika 1983; 74:149-154.
-
(1983)
Biometrika
, vol.74
, pp. 149-154
-
-
Lan, K.K.G.1
DeMets, D.L.2
-
24
-
-
0018687930
-
A multiple testing procedure for clinical trials
-
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35:549-556.
-
(1979)
Biometrics
, vol.35
, pp. 549-556
-
-
O'Brien, P.C.1
Fleming, T.R.2
-
25
-
-
9044243412
-
Fragmin during instability in Coronary Artery Disease (FRISC) study group. Low-molecular-weight heparin during instability in coronary artery disease
-
Wallentin L, Fragmin during instability in Coronary Artery Disease (FRISC) study group. Low-molecular-weight heparin during instability in coronary artery disease. Lancet 1996; 347:561-568.
-
(1996)
Lancet
, vol.347
, pp. 561-568
-
-
Wallentin, L.1
-
26
-
-
0030789174
-
Comparison of low-molecular-weight heparin with unfractionated heparin acutely and with placebo for 6 weeks in the management of unstable coronary artery disease, Fragmin in unstable coronary artery disease study (FRIC)
-
for the FRIC Investigators
-
Klein W, Buchwald A, Hillis SE, Monrad S, Sanz G, Gurpie AGG, Meer J, Olaisson E, Undeland S, Ludwig K, for the FRIC Investigators. Comparison of low-molecular-weight heparin with unfractionated heparin acutely and with placebo for 6 weeks in the management of unstable coronary artery disease, Fragmin in unstable coronary artery disease study (FRIC). Circulation 1997; 96:61-68.
-
(1997)
Circulation
, vol.96
, pp. 61-68
-
-
Klein, W.1
Buchwald, A.2
Hillis, S.E.3
Monrad, S.4
Sanz, G.5
Gurpie, A.G.G.6
Meer, J.7
Olaisson, E.8
Undeland, S.9
Ludwig, K.10
-
27
-
-
0032886394
-
Modification of sample size in group sequential trials
-
Cui L, Hung HMJ, Wang SJ. Modification of sample size in group sequential trials. Biometrics 1999; 55: 853-857.
-
(1999)
Biometrics
, vol.55
, pp. 853-857
-
-
Cui, L.1
Hung, H.M.J.2
Wang, S.J.3
|