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After TGN1412: the CHMP draft guidelines


Bhogal, N.

Hosptial Pharmacy Europe, 33, 43-44 (2007)

The EU Clinical Trials Directive 2001/20/EC, ­governing the conduct of clinical ­trials for investigational medicinal products (IMPs, defined by Article 1 Directive 2001/83/EC), embraces provisions of the Helsinki ­Declaration and operates alongside guidelines, including the International ­Conference on Harmonization (ICH) Note for ­Guidance on Good Clinical Practice (CPMP/ICH/135/95), to protect the rights, safety and ­wellbeing of trials volunteers. In reality, however, adverse reactions to IMPs are not always anticipated because of ­inherent problems with extrapolating to the clinic information from animal and in vitro ­studies. Indeed, one survey ­suggests that only around 11% of IMPs that progress to clinical ­trials are ever registered, with around half of all drug ­failures due to safety, toxicity or efficacy problems.