Healthy Skepticism Library item: 16806

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

McMahon AD, Conway DI, MacDonald TM, McInnes GT
The Unintended Consequences of Clinical Trials Regulations
PLoS Med 2009 Nov 17;
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000131

Abstract:

Summary Points

Trial regulations are damaging noncommercial research and patients.

The International Conference on Harmonisation (ICH) version of Good Clinical Practice (GCP) is inapplicable to most noncommercial research.

ICH GCP is not usually legally binding (as conceded by the regulatory authorities in the UK).

Other parts of the world should learn a lesson from the misguided trial regulations that have been created in Europe.