Concepedia

The Unintended Consequences of Clinical Trials Regulations

Alex D. McMahon, David I. Conway, Gordon T. McInnes

PLoS Medicine · 2009 · 72 citations · 14 references

DOIFull text

Open access

Concepts

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

14

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

PubMed · 2006 · 413 citations

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A New Colonialism? — Conducting Clinical Trials in India

Samiran Nundy, Chandra M Gulhati · New England Journal of Medicine · 2005 · 183 citations

, , +11

Medicines for human use (clinical trials) regulations 2004.

PubMed · 2004 · 160 citations

, , +16

Clinical trials bureaucracy: unintended consequences of well-intentioned policy

Robert M. Califf · Clinical Trials · 2006 · 95 citations

, , +16

The impact of the ‘Clinical Trials’ directive on the cost and conduct of non-commercial cancer trials in the UK

Jeff Hearn, Richard Sullivan · European Journal of Cancer · 2006 · 82 citations

, , +11