-
1
-
-
0000559516
-
Medical ethics and controlled trials
-
Hill B.A. Medical ethics and controlled trials. BMJ. 1:1963;1043-1049.
-
(1963)
BMJ
, vol.1
, pp. 1043-1049
-
-
Hill, B.A.1
-
2
-
-
0016291813
-
Allocation of subjects in medical experiments
-
Weinstein M.C. Allocation of subjects in medical experiments. N Engl J Med. 24:1974;1278-1285.
-
(1974)
N Engl J Med
, vol.24
, pp. 1278-1285
-
-
Weinstein, M.C.1
-
3
-
-
0021745695
-
The evaluation of therapies: Historical control studies
-
Gehan E.A. The evaluation of therapies: historical control studies. Stat Med. 3:1984;315-324.
-
(1984)
Stat Med
, vol.3
, pp. 315-324
-
-
Gehan, E.A.1
-
4
-
-
0025906439
-
Of mice but not of men
-
Hellman S., Hellman D.S. Of mice but not of men. N Engl J Med. 324:1991;1585-1589.
-
(1991)
N Engl J Med
, vol.324
, pp. 1585-1589
-
-
Hellman, S.1
Hellman, D.S.2
-
5
-
-
84938454203
-
The need for early randomization in the development of new drugs for AIDS
-
Chalmers T.C. The need for early randomization in the development of new drugs for AIDS. J Acquir Immune Defic Syndr. 3:1990;S10-S15.
-
(1990)
J Acquir Immune Defic Syndr
, vol.3
-
-
Chalmers, T.C.1
-
6
-
-
0023185342
-
Equipoise and the ethics of clinical research
-
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 317:1987;141-145.
-
(1987)
N Engl J Med
, vol.317
, pp. 141-145
-
-
Freedman, B.1
-
7
-
-
0033118672
-
Ethics and practice: Alternative designs for phase III randomized clinical trials
-
Palmer C.R., Rosenberger W.F. Ethics and practice: alternative designs for phase III randomized clinical trials. Control Clin Trials. 20:1999;172-186.
-
(1999)
Control Clin Trials
, vol.20
, pp. 172-186
-
-
Palmer, C.R.1
Rosenberger, W.F.2
-
8
-
-
0028070548
-
The continuing unethical use of placebo controls
-
Rothman K., Michels K. The continuing unethical use of placebo controls. N Engl J Med. 331:1994;94-98.
-
(1994)
N Engl J Med
, vol.331
, pp. 94-98
-
-
Rothman, K.1
Michels, K.2
-
9
-
-
0030228704
-
Placebo orthodoxy in clinical research I: Empirical and methodological myths
-
Freedman B., Weijer C., Cranley Glass K. Placebo orthodoxy in clinical research I: empirical and methodological myths. J Law Med Ethics. 24:1996;243-251.
-
(1996)
J Law Med Ethics
, vol.24
, pp. 243-251
-
-
Freedman, B.1
Weijer, C.2
Cranley Glass, K.3
-
10
-
-
0030229913
-
Placebo orthodoxy in clinical research II: Ethical legal and regulatory myths
-
Freedman B., Cranley Glass K., Weijer C. Placebo orthodoxy in clinical research II: ethical legal and regulatory myths. J Law Med Ethics. 24:1996;252-259.
-
(1996)
J Law Med Ethics
, vol.24
, pp. 252-259
-
-
Freedman, B.1
Cranley Glass, K.2
Weijer, C.3
-
11
-
-
0034687072
-
Placebo-controlled trials and active-control trials in the evaluation of new treatments: Part 1: Ethical and scientific issues
-
Temple R.T., Ellenberg S.S. Placebo-controlled trials and active-control trials in the evaluation of new treatments Part 1: ethical and scientific issues. Ann Intern Med. 133:2000;456-464.
-
(2000)
Ann Intern Med
, vol.133
, pp. 456-464
-
-
Temple, R.T.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 S.S., Temple R.T. Placebo-controlled trials and active-control trials in the evaluation of new treatments Part 2: practical issues and specific cases. Ann Intern Med. 133:2000;464-470.
-
(2000)
Ann Intern Med
, vol.133
, pp. 464-470
-
-
Ellenberg, S.S.1
Temple, R.T.2
-
13
-
-
0014019552
-
Ethics and clinical research
-
Beecher H.K. Ethics and clinical research. N Engl J Med. 27:1966;1354-1360.
-
(1966)
N Engl J Med
, vol.27
, pp. 1354-1360
-
-
Beecher, H.K.1
-
14
-
-
0018750520
-
A new design for randomized clinical trials
-
Zelen M. A new design for randomized clinical trials. N Engl J Med. 300:1979;1242-1245.
-
(1979)
N Engl J Med
, vol.300
, pp. 1242-1245
-
-
Zelen, M.1
-
15
-
-
0021320509
-
Randomization designs in comparative clinical trials
-
Ellenberg S.S. Randomization designs in comparative clinical trials. N Engl J Med. 310:1984;1404-1408.
-
(1984)
N Engl J Med
, vol.310
, pp. 1404-1408
-
-
Ellenberg, S.S.1
-
17
-
-
0030684073
-
Informed consent: Protection or obstacle? Some emerging issues
-
Ellenberg S.S. Informed consent: protection or obstacle? Some emerging issues. Control Clin Trials. 18:1997;628-636.
-
(1997)
Control Clin Trials
, vol.18
, pp. 628-636
-
-
Ellenberg, S.S.1
-
18
-
-
0014957018
-
Ethics in cooperative clinical trials
-
Shaw L.W., Chalmers T.C. Ethics in cooperative clinical trials. Ann N Y Acad Sci. 169:1970;487-495.
-
(1970)
Ann N Y Acad Sci
, vol.169
, pp. 487-495
-
-
Shaw, L.W.1
Chalmers, T.C.2
-
19
-
-
0032430615
-
Clinical trials and treatment effect monitoring
-
Meinert C.L. Clinical trials and treatment effect monitoring. Control Clin Trials. 19:1998;515-522.
-
(1998)
Control Clin Trials
, vol.19
, pp. 515-522
-
-
Meinert, C.L.1
-
20
-
-
0027932826
-
The clinical importance of early stopping of randomized trials in cancer treatments
-
Souhami R.L. The clinical importance of early stopping of randomized trials in cancer treatments. Stat Med. 13:1994;1293-1295.
-
(1994)
Stat Med
, vol.13
, pp. 1293-1295
-
-
Souhami, R.L.1
-
21
-
-
0034732148
-
Investigators' responsibilities for human subjects in developing countries
-
Angell M. Investigators' responsibilities for human subjects in developing countries. N Engl J Med. 342:2000;967-969.
-
(2000)
N Engl J Med
, vol.342
, pp. 967-969
-
-
Angell, M.1
-
22
-
-
0030767808
-
Unethical trials of interventions to reduce perinatal transmission of human immunodeficiency virus in developing countries
-
Lurie P., Wolfe S.M. Unethical trials of interventions to reduce perinatal transmission of human immunodeficiency virus in developing countries. N Engl J Med. 337:1997;853-856.
-
(1997)
N Engl J Med
, vol.337
, pp. 853-856
-
-
Lurie, P.1
Wolfe, S.M.2
-
23
-
-
0034757732
-
Points to consider for ethics committees in human gene therapy trials
-
Dettweiler U., Simon P. Points to consider for ethics committees in human gene therapy trials. Bioethics. 15:2001;491-500.
-
(2001)
Bioethics
, vol.15
, pp. 491-500
-
-
Dettweiler, U.1
Simon, P.2
-
24
-
-
0027471218
-
Discussion
-
Proceedings of Workshop on Practical Issues in Data Monitoring of Clinical Trials
-
Discussion. Ellenberg S.S., Geller N., Simon R., Yusuf S. Stat Med. Proceedings of Workshop on Practical Issues in Data Monitoring of Clinical Trials. 12:1993;521-525
-
(1993)
Stat Med
, vol.12
, pp. 521-525
-
-
Ellenberg, S.S.1
Geller, N.2
Simon, R.3
Yusuf, S.4
-
25
-
-
1542757334
-
A matter of life and death? the Heart Protection Study and protection of clinical trial participants
-
Migrino R.Q., Topol E.J. A matter of life and death? The Heart Protection Study and protection of clinical trial participants. Control Clin Trials. 24:2003;501-505.
-
(2003)
Control Clin Trials
, vol.24
, pp. 501-505
-
-
Migrino, R.Q.1
Topol, E.J.2
-
26
-
-
0037031061
-
MRC/BHF Heart Protection Study of cholesterol lowering simvastatin in 20, 536 high-risk individuals: A randomised placebo-controlled trial
-
Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering simvastatin in 20, 536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 360:2002;7-22.
-
(2002)
Lancet
, vol.360
, pp. 7-22
-
-
-
27
-
-
0023874973
-
Organization, review and administration of cooperative studies (Greenberg Report): A report from the Heart Special Project Committee to the National Advisory Council, May 1967
-
Heart Special Project Committee. Organization, review and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Council, May 1967. Control Clin Trials. 9:1988;137-148.
-
(1988)
Control Clin Trials
, vol.9
, pp. 137-148
-
-
Special Project Committee, H.1
-
28
-
-
0027566177
-
Proceedings of Workshop on Practical Issues in Data Monitoring of Clinical Trials
-
Ellenberg S.S., Geller N., Simon R., Yusuf S. Stat Med. Proceedings of Workshop on Practical Issues in Data Monitoring of Clinical Trials. 12:1993;415-616
-
(1993)
Stat Med
, vol.12
, pp. 415-616
-
-
Ellenberg, S.S.1
Geller, N.2
Simon, R.3
Yusuf, S.4
-
29
-
-
0027469605
-
The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases
-
Ellenberg S.S., Myers M.W., Blackwelder W.C., Hoth D.F. The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases. Stat Med. 12:1993;461-467.
-
(1993)
Stat Med
, vol.12
, pp. 461-467
-
-
Ellenberg, S.S.1
Myers, M.W.2
Blackwelder, W.C.3
Hoth, D.F.4
-
30
-
-
0023413293
-
Policies for study monitoring and interim reporting of results
-
Green S.J., Fleming T.R., O'Fallon J.R. Policies for study monitoring and interim reporting of results. J Clin Oncol. 5:1987;1477-1484.
-
(1987)
J Clin Oncol
, vol.5
, pp. 1477-1484
-
-
Green, S.J.1
Fleming, T.R.2
O'Fallon, J.R.3
-
33
-
-
0000092346
-
Repeated significance tests on accumulating data
-
Armitage P., McPherson C.K., Rowe B.C. Repeated significance tests on accumulating data. J R Stat Soc. 132A:1969;235-244.
-
(1969)
J R Stat Soc
, vol.132
, pp. 235-244
-
-
Armitage, P.1
McPherson, C.K.2
Rowe, B.C.3
-
34
-
-
0028774019
-
Proceedings of Workshop on Early Stopping Rules in Cancer Clinical Trials
-
Souhami R.L., Whitehead J. Stat Med. Proceedings of Workshop on Early Stopping Rules in Cancer Clinical Trials. 13:1994;1289-1500
-
(1994)
Stat Med
, vol.13
, pp. 1289-1500
-
-
Souhami, R.L.1
Whitehead, J.2
-
35
-
-
0035949071
-
Monitoring clinical trials - Interim data should be publicly available
-
Lilford R.J., Braunholtz D., Edwards S., Stevens A. Monitoring clinical trials - interim data should be publicly available. BMJ. 323:2001;441-442.
-
(2001)
BMJ
, vol.323
, pp. 441-442
-
-
Lilford, R.J.1
Braunholtz, D.2
Edwards, S.3
Stevens, A.4
-
36
-
-
85007699501
-
Dissemination of decisions on interim analyses needs wider debate
-
(letter)
-
Bird S.M. Dissemination of decisions on interim analyses needs wider debate. (letter) BMJ. 323:2001;1424.
-
(2001)
BMJ
, vol.323
, pp. 1424
-
-
Bird, S.M.1
-
37
-
-
85044699755
-
Interim data should not be publicly available
-
(letter)
-
Richards S.M. Interim data should not be publicly available. (letter) BMJ. 323:2001;1424.
-
(2001)
BMJ
, vol.323
, pp. 1424
-
-
Richards, S.M.1
-
38
-
-
85044703355
-
Caution may be warranted in releasing interim trial data
-
(letter)
-
Thornton H. Caution may be warranted in releasing interim trial data. (letter) BMJ. 323:2001;1424-1425.
-
(2001)
BMJ
, vol.323
, pp. 1424-1425
-
-
Thornton, H.1
-
39
-
-
0035894994
-
Several points are contentious
-
(letter)
-
Perry D. Several points are contentious. (letter) BMJ. 323:2001;1425.
-
(2001)
BMJ
, vol.323
, pp. 1425
-
-
Perry, D.1
-
40
-
-
1642312405
-
Interim data are at least as important as interim analyses
-
(letter)
-
Reidpath D. Interim data are at least as important as interim analyses. (letter) BMJ. 323:2001;1425.
-
(2001)
BMJ
, vol.323
, pp. 1425
-
-
Reidpath, D.1
-
41
-
-
0035895023
-
Latest data from START trial should be made available
-
(letter)
-
Henk J.M. Latest data from START trial should be made available. (letter) BMJ. 323:2001;1425.
-
(2001)
BMJ
, vol.323
, pp. 1425
-
-
Henk, J.M.1
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