Managerial Aspects of BNCT at a Nuclear Research Reactor

Abstract

BNCT requires the collaboration of specialists from different disciplines and often from different institutes in different countries and hence from different nationalities. BNCT is primarily the combination of nuclear technology and medicine. The fact that many individuals with no medical training will have to collaborate in the treatment of a patient is a major hurdle that cannot be overcome by organisational tools alone. Due to the fact that either a new drug or a new radiation beam or a new facility will be used, special efforts have to be made on managing such a diverse infrastructure. A guaranteed and efficiently functioning structure requires what is termed as quality management, which for BNCT has the overriding goal to ensure that the set-up at the radiation facility and the personnel involved are seen to comply with similar practices in conventional radiotherapy departments. Quality management for clinical trials is mainly regulated by guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. For BNCT, such guidelines do not exist; hence, there is the need to follow conventional practice in medicine and nuclear safety.