Implications of the BIA‐102474‐101 study for review of first‐into‐human clinical trials

@article{Eddleston2016ImplicationsOT,
  title={Implications of the BIA‐102474‐101 study for review of first‐into‐human clinical trials},
  author={M. Eddleston and A. Cohen and D. Webb},
  journal={British Journal of Clinical Pharmacology},
  year={2016},
  volume={81},
  pages={582 - 586}
}
Over the past 10 years, thousands of first‐into‐human (FIH) clinical trials have been performed in Europe, with few severe adverse events (SAEs). Each has received detailed prior safety review at both the local clinical research facility and at national drug regulatory authority level. The recent fatal SAE in the BIA‐102474‐101 clinical trial shows the limitations of this process. Although criticized for not sequentially dosing subjects both within and between cohorts – as recommended by the… Expand
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