Randomised trialomania? The multicentre liver transplant trials of tacrolimus

Multicenter liver transplant trials of the immunosuppressant tacrolimus were approved and conducted, despite the fact that Starzl and his colleagues already determined the superiority of tacrolimus over cyclosporin in their own study. The trials were the result of administrative pressure and posed a...

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Bibliographic Details
Published in:The Lancet (British edition) 1995-11, Vol.346 (8986), p.1346-1350
Main Authors: Starzl, T.E, Fung, J.J, McMichael, J.P, Todo, S, Donner, A, Eliasziw, M, Stitt, L, Meier, P
Format: Article
Language:English
Subjects:
Biological and medical sciences
Bureaucracy
Clinical trials
Cyclosporine - therapeutic use
Drug Approval - methods
Drug therapy
Graft Rejection - prevention & control
Humans
Immunomodulators
Immunosuppressive Agents - therapeutic use
Liver
Liver Transplantation
Medical sciences
Multicenter Studies as Topic
Pharmacology. Drug treatments
Prednisone - therapeutic use
Randomized Controlled Trials as Topic
Tacrolimus - therapeutic use
Transplants & implants
United States
United States Food and Drug Administration
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Summary:Multicenter liver transplant trials of the immunosuppressant tacrolimus were approved and conducted, despite the fact that Starzl and his colleagues already determined the superiority of tacrolimus over cyclosporin in their own study. The trials were the result of administrative pressure and posed an ethical quandary of randomizing treatment to "life stake" liver transplant recipients.
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(95)92349-7