Recommendations for Conducting Clinical Trials with Radiopharmaceuticals
The development of radiopharmaceuticals is essential for nuclear medicine, implementing new findings in molecular biology, drug development, and in many fields of clinical specialities, increasing its pace in particular in the field of PET and therapeutic
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Clemens Decristoforo and Serge K. Lyashchenko
Contents 41.1 Introduction: The Need for Clinical Trials with Radiopharmaceuticals
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41.2 Clinical Trials in Europe 41.2.1 Regulatory Background for Clinical Trials in the European Union 41.2.2 Clinical Trial Definitions, Application Process, and Documents to Be Prepared 41.2.3 Investigational Medicinal Product Dossier (IMPD) 41.2.4 Good Manufacturing Practices for Clinical Trials in Europe 41.2.5 Preclinical Data Requirements in Europe 41.2.6 Planning and Advice for Clinical Trials in Europe
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41.3 Clinical Trials in the United States 41.3.1 Regulatory Background for Radiopharmaceutical Clinical Trials in the United States 41.3.2 IND Application General Process 41.3.3 Exploratory IND Application (eIND) 41.3.4 Traditional IND Application (IND) 41.3.5 Expanded Access IND Application (eaIND) 41.3.6 Radioactive Drug Research Committee (RDRC) Program 41.3.7 Practical Recommendations for Conducting Clinical Trials in the United States
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References
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Learning Objectives
• Envisage the process of a clinical trial application in the European Union and in the United States. • Acquire the ability to find appropriate documents describing the legal background for clinical trials in Europe and in the United States. • List major components of clinical trial applications used in the European Union and in the United States.
C. Decristoforo (*) Department of Nuclear Medicine, Medical University of Innsbruck, Innsbruck, Austria e-mail: [email protected] S. K. Lyashchenko Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA e-mail: [email protected]
• Identify major differences and similarities between the European and the American clinical trial application submission process. • Become familiar with important considerations for conducting successful clinical trials with radiopharmaceuticals.
41.1 Introduction: The Need for Clinical Trials with Radiopharmaceuticals The development of radiopharmaceuticals is essential for nuclear medicine, implementing new findings in molecular biology, drug development, and in many fields of clinical specialities, increasing its pace in particular in the field of PET and therapeutic applications. New radionuclides are emerging; an increased need of radiopharmaceuticals as companion diagnostics and new insights in targeting of in particular tumor cells open new applications in diagnosis and therapy involving radiopharmaceuticals. A major bottleneck in the process of translating new radiopharmaceuticals into
© Springer Nature Switzerland AG 2019 D. Volterrani et al. (eds.), Nuclear Medicine Textbook, https://doi.org/10.1007/978-3-319-95564-3_41
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clinical applications lies in the increasing regulatory burden in the pharmaceutical field in general and radioactive drugs in particular. In almost every country today, radiopharmaceuticals are con
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