Letters Risks of non-oncology phase I research

Time to abandon three-phase trials?

BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i764 (Published 17 February 2016) Cite this as: BMJ 2016;352:i764
  1. Andrew V Metcalfe, associate professor in statistics1
  1. 1University of Adelaide, Adelaide, SA 5005, Australia
  1. andrew.metcalfe{at}adelaide.edu.au

Emmanuel and colleagues conclude that “concerns about the high risks of serious harm in non-oncology phase I trials do not seem to be borne out.”1 But, although the risk may be small, the consequences can be tragic.2 3

Nevertheless, randomised controlled trials (RCTs) are widely considered the gold standard for clinical research, …

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