Clinical Trials Series — Large Pharma

Clinical Trials Series — Large Pharma

To the Editor: We believe that the model of pharmaceutical clinical trials that is described by Rosenblatt (Jan. 5 issue) 1 needs rethinking. 2 , 3 Pivotal studies are unnecessarily complex, and the avoidance of composite end points would improve clarity and reduce costs. Choosing the appropriate ta...

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Veröffentlicht in:The New England journal of medicine 2017-04, Vol.376 (14), p.e28-e28
Hauptverfasser: Schellens, Jan H.M, Bernards, René, Winter, John H, Rosenblatt, Michael
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Sprache:eng
Schlagworte:
Clinical trials
Low income groups
Rotavirus
Vaccines
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container_end_page e28
container_issue 14
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container_title The New England journal of medicine
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creator Schellens, Jan H.M
Bernards, René
Winter, John H
Rosenblatt, Michael
description To the Editor: We believe that the model of pharmaceutical clinical trials that is described by Rosenblatt (Jan. 5 issue) 1 needs rethinking. 2 , 3 Pivotal studies are unnecessarily complex, and the avoidance of composite end points would improve clarity and reduce costs. Choosing the appropriate target population can make a difference. For example, in the case of the rotavirus vaccine RotaTeq, a vaccine for a disease that is self-limiting in high-income countries but potentially fatal in low-income countries, the trial might have been carried out in fewer patients at a lower cost and a higher benefit–risk ratio in low-income countries than . . .
doi_str_mv 10.1056/NEJMc1701621
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source New England Journal of Medicine Current; ProQuest Central UK/Ireland; EZB Electronic Journals Library
subjects Clinical trials
Low income groups
Rotavirus
Vaccines
title Clinical Trials Series — Large Pharma
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