Intended for healthcare professionals

Letters Phase I studies

Need for a proactive and structured approach to risk analysis when designing phase I trials

BMJ 2015; 351 doi: (Published 22 July 2015) Cite this as: BMJ 2015;351:h3899
  1. Cornelis A Van den Bogert, PhD candidate1,
  2. Adam F Cohen, chief executive officer2
  1. 1Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, University of Utrecht, Netherlands
  2. 2Centre for Human Drug Research, 2333 CL Leiden, Netherlands
  1. c.a.vandenbogert{at}

Good news from Emanuel and colleagues1—apparently, phase I clinical drug trials are safe. However, given the very low frequencies of serious adverse events, retrospective associations of trial characteristics with adverse events are of no use for predicting safety problems in future trials. None of these associations would have helped prevent the cytokine storm caused by TGN1412. This drug’s risk …

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