Do we have the proper guard rails for first-in-man clinical trials?

Consider drug efficacy before first-in-human trials

“On 17 January 2016, a healthy man was declared brain-dead after receiving an experimental drug in a first-in-human trial in France. Four of five other subjects receiving the same dose have serious, ongoing neurological complications. Investigations into the trial described many troubling safety practices, such as steep increases in dose levels delivered to sequential subjects without sufficient delays to check for safety.

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.

Image credit Richard Wilkinson.

The year since has brought intense scrutiny about how the debacle could have been anticipated and prevented. However, another issue is still largely overlooked: the duty to evaluate whether an experimental treatment is promising enough to warrant testing on people.”…

… continue reading Consider drug efficacy before first-in-human trials, by Jonathan Kimmelman and Carole Federico, Nature, 30 January 2017.

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