-
1
-
-
0003918497
-
-
Washington, DC, United States Government Printing Office, Pub no 77-3040
-
United States Food and Drug Administration: General Considerations for the Clinical Evaluation of New Drugs. Washington, DC, United States Government Printing Office, Pub no 77-3040, 1977
-
(1977)
General Considerations for the Clinical Evaluation of New Drugs
-
-
-
3
-
-
0023554115
-
Current phase I/II designs: Are they adequate?
-
Storer B, DeMets D: Current phase I/II designs: Are they adequate? J Clin Res Drug Dev 1:121-130, 1987
-
(1987)
J Clin Res Drug Dev
, vol.1
, pp. 121-130
-
-
Storer, B.1
DeMets, D.2
-
4
-
-
0027054802
-
Using toxicity grades and analysis of cancer phase I clinical trials
-
Gordon NH, Williams JKV: Using toxicity grades and analysis of cancer phase I clinical trials. Stat Med 11:2063-2075, 1992
-
(1992)
Stat Med
, vol.11
, pp. 2063-2075
-
-
Gordon, N.H.1
Williams, J.K.V.2
-
5
-
-
0002620999
-
Principles of cancer management: Chemotherapy
-
DeVita VT, Hellman S, Rosenberg SA (eds): Philadelphia, PA, Lippincott
-
DeVita VT: Principles of cancer management: Chemotherapy, in DeVita VT, Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology (ed 5). Philadelphia, PA, Lippincott, 1997, pp 333-348
-
(1997)
Cancer: Principles and Practice of Oncology (Ed 5)
, pp. 333-348
-
-
DeVita, V.T.1
-
6
-
-
0021687914
-
Clinical trials for the evaluation of cancer therapy
-
Fisher B: Clinical trials for the evaluation of cancer therapy. Cancer 54:2609-2617, 1984
-
(1984)
Cancer
, vol.54
, pp. 2609-2617
-
-
Fisher, B.1
-
7
-
-
0027524863
-
Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents
-
Ratain MJ, Mick R, Schilsky R, et al: Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. J Natl Cancer Inst 85:1637-1643, 1993
-
(1993)
J Natl Cancer Inst
, vol.85
, pp. 1637-1643
-
-
Ratain, M.J.1
Mick, R.2
Schilsky, R.3
-
8
-
-
0025924266
-
Response rates, duration of response, and dose response effects in phase I studies of antineoplastics
-
Von Hoff DD, Turner J: Response rates, duration of response, and dose response effects in phase I studies of antineoplastics. Invest New Drugs 9:115-122, 1991
-
(1991)
Invest New Drugs
, vol.9
, pp. 115-122
-
-
Von Hoff, D.D.1
Turner, J.2
-
9
-
-
0022542911
-
Therapuetic responses in phase I trials of antineoplastic agents
-
Estey E, Hoth D, Wittes R, et al: Therapuetic responses in phase I trials of antineoplastic agents. Cancer Treat Rep 70:1105-1115, 1986
-
(1986)
Cancer Treat Rep
, vol.70
, pp. 1105-1115
-
-
Estey, E.1
Hoth, D.2
Wittes, R.3
-
10
-
-
0025353690
-
Responses and toxic deaths in phase I clinical trials
-
Decoster G, Stein G, Holdener EE: Responses and toxic deaths in phase I clinical trials. Ann Oncol 2:175-181, 1990
-
(1990)
Ann Oncol
, vol.2
, pp. 175-181
-
-
Decoster, G.1
Stein, G.2
Holdener, E.E.3
-
11
-
-
0030044379
-
Design and results of phase I cancer clinical trials: Three-year experience at M.D. Anderson Cancer Center
-
Smith TL, Lee JJ, Kantarjian HM, et al: Design and results of phase I cancer clinical trials: Three-year experience at M.D. Anderson Cancer Center. J Clin Oncol 14:287-295, 1996
-
(1996)
J Clin Oncol
, vol.14
, pp. 287-295
-
-
Smith, T.L.1
Lee, J.J.2
Kantarjian, H.M.3
-
12
-
-
0029002997
-
Perceptions of cancer patients and their physicians involved in phase I trials
-
Daugherty CK, Ratain MJ, Grochowski E, et al: Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062-1072, 1995
-
(1995)
J Clin Oncol
, vol.13
, pp. 1062-1072
-
-
Daugherty, C.K.1
Ratain, M.J.2
Grochowski, E.3
-
13
-
-
0019948583
-
On the nature and ethics of phase I cancer trials
-
Lipsett MB: On the nature and ethics of phase I cancer trials. JAMA 248:941-942, 1982
-
(1982)
JAMA
, vol.248
, pp. 941-942
-
-
Lipsett, M.B.1
-
14
-
-
0022898168
-
The ethical dilemma of phase I clinical trials
-
Markman M: The ethical dilemma of phase I clinical trials. CA Cancer J Clin 1986 36:367-369, 1986
-
(1986)
CA Cancer J Clin 1986
, vol.36
, pp. 367-369
-
-
Markman, M.1
-
15
-
-
0025269647
-
Ethical considerations in phase I clinical trials
-
Sass HM: Ethical considerations in phase I clinical trials. Onkologie 13:85-88, 1990
-
(1990)
Onkologie
, vol.13
, pp. 85-88
-
-
Sass, H.M.1
-
16
-
-
0027361275
-
Early cancer clinical trials: Safety, numbers, and consent
-
Hawkins MJ: Early cancer clinical trials: Safety, numbers, and consent. J Natl Cancer Inst 85:1618-1619, 1993
-
(1993)
J Natl Cancer Inst
, vol.85
, pp. 1618-1619
-
-
Hawkins, M.J.1
-
18
-
-
0003408414
-
-
New York, NY, Oxford University Press
-
Faden RR, Beauchamp TL, King NMP: A History and Theory of Informed Consent. New York, NY, Oxford University Press, 1986
-
(1986)
A History and Theory of Informed Consent
-
-
Faden, R.R.1
Beauchamp, T.L.2
King, N.M.P.3
-
19
-
-
0022819257
-
Ethical problems in clinical trials
-
Schafner KF: Ethical problems in clinical trials. J Med Philos 11:297-315, 1986
-
(1986)
J Med Philos
, vol.11
, pp. 297-315
-
-
Schafner, K.F.1
-
20
-
-
0021086229
-
Readability of informed consent forms for research in a Veterans Administration medical center
-
Baker MT, Taub HA: Readability of informed consent forms for research in a Veterans Administration medical center. JAMA 250:2646-2648, 1983
-
(1983)
JAMA
, vol.250
, pp. 2646-2648
-
-
Baker, M.T.1
Taub, H.A.2
-
21
-
-
0024454770
-
Research consent forms: Continued unreadability and increasing length
-
LoVerde ME, Prochazka AV, Byyny RL: Research consent forms: Continued unreadability and increasing length. J Gen Int Med 4:410-412, 1989
-
(1989)
J Gen Int Med
, vol.4
, pp. 410-412
-
-
LoVerde, M.E.1
Prochazka, A.V.2
Byyny, R.L.3
-
22
-
-
0030298360
-
Shared understanding for informed consent: The relevance of psychological research on the provision of information
-
Kent G: Shared understanding for informed consent: The relevance of psychological research on the provision of information. Soc Sci Med 43:1517-1524, 1996
-
(1996)
Soc Sci Med
, vol.43
, pp. 1517-1524
-
-
Kent, G.1
-
23
-
-
0008596557
-
Ethical issues in the clinical research of cancer
-
DeVita VT, Hellman S, Rosenberg SA (eds): Philadelphia, PA, Lippincott
-
Daugherty CK, Ratain MJ, Siegler M: Ethical issues in the clinical research of cancer, in DeVita VT, Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology (ed 5). Philadelphia, PA, Lippincott, 1996, pp 534-542
-
(1996)
Cancer: Principles and Practice of Oncology (Ed 5)
, pp. 534-542
-
-
Daugherty, C.K.1
Ratain, M.J.2
Siegler, M.3
-
24
-
-
0028910825
-
Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients
-
Tomamichel M, Sessa C, Herzig S, et al: Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients. Ann Oncol 6:321-323, 1995
-
(1995)
Ann Oncol
, vol.6
, pp. 321-323
-
-
Tomamichel, M.1
Sessa, C.2
Herzig, S.3
-
25
-
-
0028957476
-
Pushing the envelope: Informed consent in phase I cancer trials
-
Daugherty CK, Ratain MJ, Siegler M: Pushing the envelope: Informed consent in phase I cancer trials. Ann Oncol 6:321-323, 1995
-
(1995)
Ann Oncol
, vol.6
, pp. 321-323
-
-
Daugherty, C.K.1
Ratain, M.J.2
Siegler, M.3
-
26
-
-
0029262555
-
Shading the truth in seeking informed consent for research purposes
-
Bok S: Shading the truth in seeking informed consent for research purposes. Kennedy Inst Ethics J 5:1-17, 1995
-
(1995)
Kennedy Inst Ethics J
, vol.5
, pp. 1-17
-
-
Bok, S.1
-
27
-
-
0027034483
-
Demarcating research and treatment: A systematic approach for the analysis of the ethics of clinical research
-
Freedman B, Fuks A, Weijer C: Demarcating research and treatment: A systematic approach for the analysis of the ethics of clinical research. Clin Res 40:655-660, 1992
-
(1992)
Clin Res
, vol.40
, pp. 655-660
-
-
Freedman, B.1
Fuks, A.2
Weijer, C.3
-
28
-
-
0030950354
-
Patients in phase I trials of anticancer agents in Japan: Motivation, comprehension and expectations
-
Itoh K, Sasaki Y, Fujii H, et al: Patients in phase I trials of anticancer agents in Japan: Motivation, comprehension and expectations. Br J Cancer 76:107-113, 1997
-
(1997)
Br J Cancer
, vol.76
, pp. 107-113
-
-
Itoh, K.1
Sasaki, Y.2
Fujii, H.3
-
29
-
-
0023184783
-
Pharmacokinetically guided dose escalation in phase I clinical trials. Commentary and proposed guidelines
-
EORTC Pharmacokinetics and Metabolism Group. Pharmacokinetically guided dose escalation in phase I clinical trials. Commentary and proposed guidelines. Eur J Cancer Clin Oncol 23:1083-1087, 1987
-
(1987)
Eur J Cancer Clin Oncol
, vol.23
, pp. 1083-1087
-
-
-
30
-
-
0025360796
-
Pharmacologically guided phase I clinical trials based upon preclinical drug development
-
Collins JM, Greishaber CK, Chabner BA: Pharmacologically guided phase I clinical trials based upon preclinical drug development. J Natl Cancer Inst 82:1321-1326, 1990
-
(1990)
J Natl Cancer Inst
, vol.82
, pp. 1321-1326
-
-
Collins, J.M.1
Greishaber, C.K.2
Chabner, B.A.3
-
31
-
-
0027499297
-
Model-guided determination of maximum-tolerated dose in phase I clinical trials: Evidence for increased precision
-
Mick R, Ratain MJ: Model-guided determination of maximum-tolerated dose in phase I clinical trials: Evidence for increased precision. J Natl Cancer Inst 85:217-223, 1993
-
(1993)
J Natl Cancer Inst
, vol.85
, pp. 217-223
-
-
Mick, R.1
Ratain, M.J.2
-
32
-
-
0026572101
-
The impact of pharmacokinetically guided dose escalation strategies in phase I clinical trials: Critical evaluation and recommendations for future studies
-
Graham MA, Workman P: The impact of pharmacokinetically guided dose escalation strategies in phase I clinical trials: Critical evaluation and recommendations for future studies. Ann Oncol 3:339-347, 1992
-
(1992)
Ann Oncol
, vol.3
, pp. 339-347
-
-
Graham, M.A.1
Workman, P.2
-
33
-
-
0025203416
-
Cohort-specific consent: An honest approach to phase I cancer studies
-
Freedman B: Cohort-specific consent: An honest approach to phase I cancer studies. IRB Rev Human Subjects Res 12:5-7, 1990
-
(1990)
IRB Rev Human Subjects Res
, vol.12
, pp. 5-7
-
-
Freedman, B.1
-
36
-
-
0030990804
-
Learning from our patients: One subject's impact on clinical trial research and informed consent
-
Daugherty CK, Ratain MJ, Siegler M, et al: Learning from our patients: One subject's impact on clinical trial research and informed consent. Ann Int Med 126:892-897, 1997
-
(1997)
Ann Int Med
, vol.126
, pp. 892-897
-
-
Daugherty, C.K.1
Ratain, M.J.2
Siegler, M.3
-
37
-
-
0344402603
-
-
Final Report of the President's Advisory Committee on the Human Radiation Experiments. New York, NY, Oxford University Press
-
Final Report of the President's Advisory Committee on the Human Radiation Experiments. New York, NY, Oxford University Press, 1996
-
(1996)
-
-
-
38
-
-
0029927575
-
The impact of disease severity on the informed consent process in clinical research
-
Schaeffer MH, Krantz DA, Wichman A, et al: The impact of disease severity on the informed consent process in clinical research. Am J Med 100:261-268, 1996
-
(1996)
Am J Med
, vol.100
, pp. 261-268
-
-
Schaeffer, M.H.1
Krantz, D.A.2
Wichman, A.3
|