After TGN1412: the CHMP draft guidelines
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.