Ethical and Regulatory Issues for Clinical Trials in Xenotransplantation

Erythropoiesis stimulating agents have been used for more than a decade in patients with chronic kidney disease, malignancy, and other disease states where anemia is common. Recently, several clinical trials have questioned the safety and efficacy of these agents. Thrombosis and increase in tumor progression as well as a potential increase in mortality have been noted in some trials and have generated growing concern regarding whether these agents should remain on the US market. Subsequently, reimbursement from some payers for erythropoiesis stimulating agent administration has become somewhat restrictive. We address the pharmacology, pharmacokinetics, pharmacodynamics, safety, efficacy, and pharmacoeconomics of erythropoiesis stimulating agents as well as emerging regulatory issues pertaining to the administration of erythropoiesis stimulating agents.

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Regulatory issues for clinical trials at EORTC

European Journal of Cancer ◽

10.1016/s0959-8049(01)00443-9 ◽

2002 ◽

Vol 38 ◽

pp. 142-146 ◽

Cited By ~ 3

Author(s):

A.J. Baeyens ◽

D. Lacombe

Keyword(s):

Clinical Trials ◽

Regulatory Issues

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Clinical Trials and Regulatory Issues in Developing Countries

AIDS ◽

10.1097/00002030-200102001-00097 ◽

2001 ◽

Vol 15 ◽

pp. S66-S68 ◽

Cited By ~ 1

Author(s):

Helen Rees

Keyword(s):

Developing Countries ◽

Clinical Trials ◽

Regulatory Issues

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Adjustment of Treatment Effect for Covariates in Clinical Trials: Statistical and Regulatory Issues

Drug Information Journal ◽

10.1177/009286150003400220 ◽

2000 ◽

Vol 34 (2) ◽

pp. 511-523 ◽

Cited By ~ 30

Author(s):

Dongsheng Tu ◽

Katherine Shalay ◽

Joseph Pater

Keyword(s):

Clinical Trials ◽

Treatment Effect ◽

Regulatory Issues

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Regulatory Issues: An Academic Viewpoint From Asia (Ex-Japan)

International Psychogeriatrics ◽

10.1017/s1041610203009359 ◽

2003 ◽

Vol 15 (S1) ◽

pp. 287-291 ◽

Cited By ~ 1

Author(s):

Christopher P. L.-H. Chen

Keyword(s):

Clinical Trials ◽

Ethical Issues ◽

Regulatory Issues ◽

Large Patient ◽

Regulatory Reforms

Regulatory reforms, together with large patient pools and increasing numbers of well-trained clinicians, have facilitated the development of clinical trials in Asia. Current regulatory and ethical issues are discussed.

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