PLoS Medicine (Nov 2009)

The unintended consequences of clinical trials regulations.

  • Alex D McMahon,
  • David I Conway,
  • Tom M Macdonald,
  • Gordon T McInnes

DOI
https://doi.org/10.1371/journal.pmed.1000131
Journal volume & issue
Vol. 3, no. 11
p. e1000131

Abstract

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Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.