Regulatory issues for clinical trials at EORTC: the way forward. European Organisation for Research and Treatment of Cancer.
Since the Declaration of Helsinki, the performance of clinical trials is subject to ethical and gradually also legal requirements. As the EORTC is performing clinical trials in more then 30 countries, it gained expertise in the field of Regulatory Affairs of all those countries. This paper intends to address the general approach with regard to European Regulatory Affairs. Furthermore, it is focusing on the role of the EORTC at the level of the competent regulatory authorities. As recently things are moving and changing on a European level, it describes the perception of the current and future European regulatory framework, and last, but not least, it is explained in what respect the achievements of the EORTC could be of benefit to society when defining their cancer treatment policies.
Baeyens
A J
AJ
EORTC Data Center, Avenue E. Mounier 83, bte 11, B-1200, Brussels, Belgium. aba@eortc.be
Lacombe
D
D
D000970:Antineoplastic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D005060:Europe; D006801:Humans; D007390:International Agencies; D007883:Legislation, Medical; D008495:Medical Oncology; D009369:Neoplasms / Q000628:therapy
D000970:Antineoplastic Agents