The unintended consequences of clinical trials regulations.

PLoS Medicine
Alex D McMahonGordon T McInnes

Abstract

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.

References

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Citations

Jun 20, 2019·Journal of Evidence-based Medicine·Christoper A Alarcon-RuizAntonio M Quispe
Jul 4, 2020·BMJ Health & Care Informatics·Philip Anthony HeslopMiles Witham
Aug 9, 2016·Global Health Action·Yodi MahendradhataVaralakshmi Elango
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Sep 10, 2014·Internal and Emergency Medicine·Agostino ColliPiergiorgio Duca
Aug 6, 2019·British Journal of Cancer·Monica TangJohn Zalcberg
Sep 13, 2013·The New England Journal of Medicine·Christina ReithSalim Yusuf
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Feb 23, 2021·Clinical Trials : Journal of the Society for Clinical Trials·William J CraggSally P Stenning
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Aug 2, 2021·BMC Medical Research Methodology·Markus Harboe OlsenUNKNOWN SafeBoosC-III Trial Group
Nov 16, 2010·Trends in Molecular Medicine·Graziella PellegriniMichele De Luca

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