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 thera
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Andrea Wittig and Wolfgang A.G. Sauerwein
Contents 19.1
Introduction................................................................................................................ 369
19.2
Design of Clinical Trials ............................................................................................ 371 19.2.1 Preclinical Studies ........................................................................................... 372
19.3
Clinical Studies........................................................................................................... 19.3.1 Phase 0 ............................................................................................................ 19.3.2 Phase I ............................................................................................................. 19.3.3 Phase II............................................................................................................ 19.3.4 Phase III ..........................................................................................................
19.4
Laws and Regulations................................................................................................ 374
19.5
Ethical Conduct ......................................................................................................... 375
19.6
Safety and Quality Assurance................................................................................... 375
References ..............................................................................................................................
19.1
373 373 373 374 374
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Introduction
In oncology, scientists are constantly searching to develop innovative, more effective, and less toxic treatments to improve local tumor control, survival of patients, and quality of life. Among many others, Boron Neutron Capture Therapy (BNCT) is one innovative approach to reach this goal. A. Wittig (*) Department of Radiotherapy and Radiation Oncology, Philipps-University Marburg, Marburg, Germany e-mail: [email protected] W.A.G. Sauerwein NCTeam, Department of Radiation Oncology, University Hospital Essen, University Duisburg-Essen, D-45122, Essen, Germany W.A.G. Sauerwein et al. (eds.), Neutron Capture Therapy, DOI 10.1007/978-3-642-31334-9_19, © Springer-Verlag Berlin Heidelberg 2012
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A. Wittig and W.A.G. Sauerwein
Following positive preclinical investigations, clinical trials are essential in the developmental process of innovative approaches, to prove a new treatment safe and efficient. To ensure protection of research subjects, the conduction of clinical trials is strictly regulated by national laws based on international guidelines. These complex rules were primarily developed for investigating new drugs but have been extended to medicinal products and therapeutic procedures for humans in a general way including “advanced therapies.” The trial strategy to develop a new treatment has been well established for drugs. However, a clear design for clinical trials to test and
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