Clinical Trials in BNCT: A Challenging Task
Clinical trials are essential for medical progress as new treatments must be proven to be safe and efficient before eventually accepted as standard. The treatment concept of Boron Neutron Capture Therapy (BNCT) varies fundamentally from conventional therapies. The main distinctions are the binary nature of the treatment principle, which requires investigation of a compound susceptible of targeting tumor cells however without an own therapeutic effect. Radiation facilities and beams used for BNCT to date differ considerably not only from facilities and beams used for conventional radiotherapy, but beams used for BNCT also differ among themselves and often must first be licensed for patient treatments. Therefore, the development of BNCT to treatment modality needs strategies, which are based on the classical trial concept but meet the challenges and characteristics of BNCT. Understood, all applicable laws and regulations for conducting clinical trials must be respected. These aspects make clinical trials in BNCT a challenging task for the clinical scientists as well as for the regulatory authorities.
KeywordsBoron Neutron Capture Therapy Binary Nature Subtherapeutic Dose Clinical Trial Protocol Trial Concept
- 3.Sauerwein W, Zurlo A (2002) The EORTC Boron Neutron Capture Therapy Group: achievements and future perspectives. Eur J Cancer 38 Suppl 4 S31–34Google Scholar
- 6.Wittig A, Malago M, Collette L, Huiskamp R, Buhrmann S, Nievaart V et al (2008) Uptake of two 10B-compounds in liver metastases of colorectal adenocarcinoma for extracorporeal irradiation with boron neutron capture therapy (EORTC Trial 11001). Int J Cancer 122(5):1164–1171PubMedCrossRefGoogle Scholar
- 7.ICH. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/eudralex_en.htm. Accessed on 2012
- 8.European Commission. The rules governing medicinal products in the European Union. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/eudralex_en.htm. Accessed on 2012
- 9.U.S. Food and Drug Administration, regulatory guidance. Research List of Guidance Documents. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm310704.htm. Accessed on 2012