Consider drug efficacy before first-in-human trials

Consider drug efficacy before first-in-human trials

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Ethical review boards must focus on clinical promise as well as safety to hold the first tests of drugs in humans to a higher standard, say Jonathan Kimmelman and Carole Federico.
4 Feb 2017 - General
Thank you for sharing the article Marinelle Castro . It was also quite surprising to hear that clinical efficacy is not required when performing testing in humans. This is because it would be really wasteful if there is a situation comes whereby a medication is found to be safe but not effective. I have participated in such trials as a subject and investigator, but for the ones which i was in had some evidence of...
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I am very surprised to learn that research evaluators in Europe and America do not require evidence of clinical efficacy prior to approving the application for human trials. All the while I thought that this was a requirement by research evaluators, and even more by bioethics board review committee. Does anybody have any experience in participating in such trials? If so, can you please share your thoughts and experience regarding this issue. If this is the case, then evaluators might have to rev...
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