Addressing the Ethical Challenges of First-inHuman Trials

@inproceedings{Chapman2011AddressingTE,
  title={Addressing the Ethical Challenges of First-inHuman Trials},
  author={Audrey R. Chapman},
  year={2011}
}
Phase I clinical trials raise ethical challenges, particularly the Phase I trials that involve a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials. The ethical appropriateness of clinical research requires having a favorable risk-to-benefit ratio and protecting patients from excessive risk, but both of these standards may be difficult to assess and to achieve in Phase I trials. There are no widely accepted standards for judgments concerning risk… CONTINUE READING

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