| Ruediger Haecker and Paolo Marinelli at RCC Ltd examine the guidelines and regulations faced by sponsors and investigators at the interface between non-clinical and early clinical development
The first administration of a new investigational medicinal product in humans is a very important step in the development of a new drug. The transition from non-clinical to early clinical development marks a milestone in the destiny of the compound. The safety issues and the pharmacokinetic behaviour of the new medicine, predicted in the non-clinical studies must then be investigated in human volunteers. The expected ‘best case’ is for promising non-clinical results, obtained in vitro or in animals, to be confirmed, at least in principle, in humans.
In view of the pivotal role of a meaningful clinical Phase I trial, it is rather surprising that, up until the end of 2006, no consistent guidance document existed that dealt with: quality aspects; scientifically-based calculations of the first dose in man; the conduct and sequence of treatment; or dose escalation schemes for a new drug. Regulations and recommendations for the clinical development can, however, be found in various publications from different sources.
DIRECTIVE 2001/20/EC
General legal advice and a framework is given for the European Union (EU) by Directive 2001/20/EC, which addresses the implementation of good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use. In this Directive the general precautions for all the different types of clinical trials are laid down. This includes: general rules for the application of good manufacturing practice (GMP) for the investigational medicinal product, protection of clinical trial subjects; measures for the establishment and operation of ethics committees; and the responsibility of the competent authorities of the member states for the authorisation of each individual clinical trial. |
