Safety of First-in-Human Trials – Are Volunteers Really the Best Participants?

First-in-human clinical trials are safe (‘only’ two deaths among 305,000 volunteers), and an editorial in the New England Journal of Medicine describes how they are being regulated to make them safer still.[1] But I wonder why paid volunteers are used instead of people with the disease concerned. Not that any less care would be required, but it seems that people affected by the target disease have ‘skin in the game’ and would be very happy to make an altruistic gesture or run whatever residual risk cannot be regulated away. After all, no one tests anti-cancer drugs in non-affected volunteers. Comments please, especially from patients and their carers.

— Richard Lilford, CLAHRC WM Director


  1. Bonini S, & Rasi G. First-in-Human Clinical Trials – What We Can Learn from Tragic Failures. New Engl J Med. 2016; 375: 1788-9.

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